SYNCHROMED™ III 8667-20 (UDI 00763000597023)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,937 adverse event reports that list this exact device (DI 00763000597023), received between Feb 6, 2024 and Sep 30, 2026 — classified as 1 death, 737 injuries, 1,199 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (944 reports).

40 other recalls cover devices cleared under the same FDA submission (P860004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,937 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952757 ↗
• MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951535 ↗
• MalfunctionSep 30, 2026Communication or Transmission Problem; Environmental Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951096 ↗
• MalfunctionSep 30, 2026Application Program Problem; Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950992 ↗
• MalfunctionSep 30, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950833 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50949733 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information; Paresthesia; Vomiting

  MAUDE report 50948585 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient who was receiving Morphine Drug via an implantable pump for non-malignant pain. It was reported that within less than 3 hours they felt a big giant rush go into their head, and they told their husband that the morphine had gotten on their bloodstream. They knew they were not going to be able to keep the pump but stated they did not think it was an emergency situation at the time. They stated their husband then noticed they were not breathing and shook them until they answered. The patient stated they kept saying they were tired and needed to go to sleep. Their husband drug them to the car and drove to the emergency room. They stated the ER 'narcanned' them as they were coming in the door, and their husband told them there was supposed to be someone on call 24/7 to turn the pump off. They stated the hospital called their healthcare provider (HCP). The patient stated they were overdosed, dying, and throwing up over and over because they were narcanned at least 4-5 times in the hospital. The patient stated they threw up an entire bucket and had to have IV's put in to give them fluids because they were throwing up so much. They reiterated that th

  Patient problems: Ambulation or Postural Difficulties; Apnea; Dysphagia/ Odynophagia; Emotional Changes; Fatigue; Insufficient Information; Scar Tissue; Shaking/Tremors; Vomiting; Weight Changes

  MAUDE report 50946625 ↗
• InjurySep 29, 2026Insufficient Flow or Under Infusion; Obstruction of Flow; Infusion or Flow Problem

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937606 ↗
• MalfunctionSep 29, 2026Communication or Transmission Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936620 ↗
• MalfunctionSep 29, 2026Failure to Power Up; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933873 ↗
• MalfunctionSep 29, 2026Application Program Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933256 ↗
• InjurySep 28, 2026Infusion or Flow Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50926514 ↗
• InjurySep 28, 2026Improper Flow or Infusion; Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924285 ↗
• MalfunctionSep 28, 2026Protective Measures Problem; Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923532 ↗
• InjurySep 28, 2026Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923296 ↗
• MalfunctionSep 28, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923274 ↗
• MalfunctionSep 28, 2026Battery Problem; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915987 ↗
• MalfunctionSep 28, 2026Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914509 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient representative (caller) regarding a patient who was receiving Dilaudid via an implantable pump for non-malignant pain. It was reported that the patient was hospitalized and needed to undergo an MRI. The caller stated that the pump had been removed due to infection, but the catheter remained in place. The caller requested documentation indicating that the patient could safely undergo an MRI with the catheter still in place. When asked for event date, caller stated the pump was removed in October or November 2025. MRI guidelines were reviewed and the caller was instructed to have the MRI facility call if they needed to verify the information.

  Patient problems: Unspecified Infection

  MAUDE report 50914370 ↗
• InjurySep 28, 2026Insufficient Device Problem Information

  Information was received from a patient who was receiving unknown drug via an implantable pump for non-malignant pain. It was reported that the patient stated that the patient had a new pump.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914261 ↗
• MalfunctionSep 28, 2026Application Program Freezes or Fails to Launch

  Information was received from a patient who was receiving Morphine Drug via an implantable pump for spinal pain indications. It was reported that the handset was not working. They said that they got stimulation every 3 hours "[understood to be boluses]". The patient said the issue started about 3 weeks ago. The patient mentioned they keep a timer on the handset, and the timer was never the correct time for one. The agent asked if patient has recently had a change in her therapy and patient said they just filled the pump yesterday and they increased the amount of medication that it was going to administer, but they didn't change the time. During the call, the patient stated it started connecting out of the blue, and the patient stated at times it took 20 minutes to connect, and it sat at 90%. They stated it would work when it wanted to. The agent walked the patient through clearing the data. The patient was able to connect to the application. The troubleshooting steps that were taken on the call resolved the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913941 ↗
• MalfunctionSep 28, 2026Application Program Freezes or Fails to Launch

  Information was received from a patient, receiving unknown drug via an implantable infusion pump for non-malignant pain, regarding an external device. It was reported that the patient needed to clear the data because their device was taking 15 minutes to get a bolus. The Agent walked the patient through clearing the data. The patient confirmed they were able to connect without the lag. The patient would call back for further assistance. The patient mentioned about their prior handset replacement and communicator issue. *See related event (b)(4) regarding prior handset replacement and communicator issue*.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913766 ↗
• DeathSep 25, 2026Infusion or Flow Problem

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider) regarding a patient who was receiving Gablofen (1,000mcg.ml at 250mcg/day) via an implantable pump for unknown indications for use. It was reported that the patient was having withdrawal symptoms. Patient was titrated by managing physician. A dye study was done and they could not aspirate the cath eter. The catheter was completely replaced and the issue was resolved. Death isn¿t confirmed to have anything to do with pump or the surgery as managing physician didn¿t have details. Additional information was received from the healthcare provider (HCP) stating the patient experienced withdrawal symptoms and a catheter dye study was done, at which time the catheter could not be aspirated. On (b)(6) 2026, the patient underwent intraventricular catheter revision. The patient was seen on (b)(6) 2026 and was doing well at that time. The patient was not in withdrawal and no dosing changes were made. Also at that time, it was noted that there was some fluid around the incision site on the scalp, but it was unknown what the fluid was as it was not sampled. The HCP indicated that it was likely seros

  Patient problems: Apnea; Fluid Discharge; Insufficient Information

  MAUDE report 50900308 ↗
• MalfunctionSep 25, 2026Battery Problem

  Information was received from a patient (pt) who was receiving Unknown Drug via an implantable pump for non-malignant pain indications for use. It was reported that the patient reported having trouble with the communicator and handset. Pt stated the issue began about a month ago, when the communicator started failing to hold a charge. Pt stated the problem has been present for a while but has gotten worse. They added that the communicator would power on, but it would not hold a charge long enough to be used for a bolus delivery. Pt confirmed they had attempted to use different cords and outlets, but the issue persisted. Agent had the patient reset the communicator, but the orange light remained on even after leaving it charged overnight. When asked how long the battery lasts, the patient said it does not last and reported receiving a low communicator battery error message: service code 388, noting they couldn't even get a bolus. Agent sent a request to repair to replace the communicator and transferred patient to Healthcare IT Support Services (HCIT) for the handset issue. The patient was transferred back by HCIT. The patient reported receiving system error service code 156 and sta

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898275 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P860004. One submission often covers many models, so check the product and lot details in each record.

• Z-2201-2026 · Apr 8, 2026 · Open, Classified
  Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900
• Z-1506-2025 · Jan 9, 2025 · Open, Classified
  A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
• Z-2352-2024 · May 10, 2024 · Open, Classified
  Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
• Z-0615-2024 · Nov 13, 2023 · Open, Classified
  Medtronic SynchroMed II, Model 8637-40, Programmable pump
• Z-0614-2024 · Nov 13, 2023 · Open, Classified
  Medtronic SynchroMed II, Model 8637-20, Programmable pump
• Z-0522-2024 · Jul 13, 2020 · Completed
  Medtronic SynchroMed, Model A10
• Z-0508-2020 · Oct 11, 2019 · Terminated
  Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
• Z-0537-2018 · Sep 21, 2017 · Terminated
  Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrath
• Z-0896-2018 · Aug 9, 2017 · Open, Classified
  Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of a
• Z-0788-2017 · Oct 3, 2016 · Terminated
  Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 Sy
• Z-1271-2016 · Feb 9, 2016 · Terminated
  Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
• Z-1681-2015 · Apr 10, 2015 · Terminated
  Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an
• Z-1060-2011 · Jan 14, 2011 · Terminated
  Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follow
• Z-1062-2011 · Jan 14, 2011 · Terminated
  Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion
• Z-1061-2011 · Jan 14, 2011 · Terminated
  Medtronic SynchroMed implantable drug pump Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566 The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits ar

…and 25 more.