# P860004: Medtronic (R) Synchromed (TM) Pump & Infusion System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Mar 14, 1988 after 770 days
- Product code: LKK (Pump, Infusion, Implanted, Programmable)
- Device class: 3
- Recalls of this device: 40 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 8, 2026 · Class II · Z-2201-2026: Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. Howe
- Jan 9, 2025 · Class II · Z-1506-2025: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
- May 10, 2024 · Class II · Z-2352-2024: Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which ma
- Nov 13, 2023 · Class II · Z-0615-2024: Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will
- Nov 13, 2023 · Class II · Z-0614-2024: Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will
- Jul 13, 2020 · Class II · Z-0522-2024: The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infu
- Oct 11, 2019 · Class I · Z-0508-2020: There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.
- Sep 21, 2017 · Class III · Z-0537-2018: There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the 
- Aug 9, 2017 · Class II · Z-0896-2018: Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.
- Oct 3, 2016 · Class I · Z-0788-2017: Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to versio
- Feb 9, 2016 · Class II · Z-1271-2016: Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer packa
- Apr 10, 2015 · Class II · Z-1681-2015: Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.
- Jan 14, 2011 · Not classified · Z-1061-2011: This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management rec
- Jan 14, 2011 · Not classified · Z-1062-2011: This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management rec
- Jan 14, 2011 · Not classified · Z-1060-2011: This letter provides important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure, and important patient management rec
- Jul 1, 2009 · Not classified · Z-2276-2009: This recall is related to the potential for reduced battery performance in a small percentage of Medtronic Model 8637 SynchroMed II pumps with batteries manufactured during two distinct time periods p
- Mar 23, 2009 · Not classified · Z-1214-2010: Routine monitoring of Medtronic's vigilance program identified user related programming errors. Medtronic has received reports of both overdose and underdose that were the result of programming use of
- Apr 14, 2008 · Not classified · Z-2174-2008: The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the contin
- Apr 14, 2008 · Not classified · Z-2171-2008: The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the contin
- Apr 14, 2008 · Not classified · Z-2173-2008: The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the contin
- Apr 14, 2008 · Not classified · Z-2172-2008: The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the contin
- Jan 16, 2008 · Not classified · Z-1153-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1146-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1149-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1147-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1144-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1148-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1151-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1150-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1142-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1152-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1145-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1143-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Jan 16, 2008 · Not classified · Z-1154-2008: Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass format
- Aug 3, 2007 · Not classified · Z-0739-2008: Pump motor stall due to gear shaft wear
- Jul 21, 2006 · Not classified · Z-1415-06: Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by
- Jul 21, 2006 · Not classified · Z-1414-06: Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by
- Nov 19, 2004 · Not classified · Z-0391-05: Outer package of Lioresal Intrethecal Refill Kit, model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 
- Aug 24, 2004 · Not classified · Z-1334-04: With the Model 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Programmer, users may have mistakenly ent
- Jul 23, 2004 · Not classified · Z-1384-04: The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is l

Source page: https://510kreport.com/device/P860004
Methodology: https://510kreport.com/methodology