SynchroMed® II 8637-20 (UDI 00643169530119)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,920 adverse event reports that list this exact device (DI 00643169530119), received between Aug 11, 2017 and Aug 10, 2026 — classified as 4 deaths, 1,272 injuries, 644 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (264 reports).

1 FDA recall record name this device's identifier, 1 still open.

39 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 13, 2023Class IIOpen, Classified

   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 not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.

   Z-0614-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,920 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Adverse Event Without Identified Device or Use Problem; Data Problem

  Information was received from a manufacturer's representative (Rep) regarding a patient receiving bupivacaine (15mg/mL at .742mg/day) and morphine (20mg/mL at .989mg/day) via an implantable infusion pump for spinal pain indications for use. It was reported that the patient had a refill on (b)(6)2026 and the session report read that the End of Service (EOS) date was (b)(6) 2026. The Rep stated the patient heard the pump start alarming (b)(6)2026 and symptoms began today, (b)(6)2026, and the patient was in the Emergency Room (ER) now. The Rep stated that the patient was having withdrawal symptoms. Technical Services reviewed that based on the implant date, EOS at this time would be expected. The Rep read the logs, and the Elective Replacement Indicator (ERI) date was (b)(6)2026 and the EOS date was (b)(6)2026. Technical Services was unable to explain why the logs were reading incorrect ERI and EOS dates. Technical Services reviewed that the pump would need to be replaced and the reports investigated further. The session report from (b))(6)2026 indicated the estimated EOS date was (b)(6)2026 and indicated in the logs a non-critical alarm for ERI on (b)(6)2026 at 12:13pm. It was noted

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194399 ↗
• MalfunctionJul 1, 2026Obstruction of Flow; Failure to Disconnect; Infusion or Flow Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS PREVI OUSLY RECEIVING MORPHINE DRUG VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REPLACEMENT OF PUMP WHICH HAD BEEN INACTIVE/SHUT OFF FOR SEVERAL YEARS PER THE PATIENT'S REPORT. THEY WERE ABLE TO INTERROGATE THE PATIENT'S DEVICE BUT WAS NOT ABLE RETRIEVE ANY OF THEIR OLD SETTINGS DUE TO PUMP BEING SHUT DOWN. THEY WERE ABLE TO DETERMINE THAT THE PREVIOUS CATHETER VOLUME WAS 0.187 ML, AND WHEN DIVIDED BY 0.0022 (ML PER CM), THEY WERE ABLE TO DETERMINE THAT THE CATHETER LENGTH WAS 85 CM. THE HCP WAS ORIGINALLY UNABLE TO ASPIRATE THE CATHETER ACCESS PORT (CAP). THE REP RECOMMENDED FIRST DISCONNECTING AND CLEANING OUT THE PUMP SEGMENT WHICH THE HCP DID AND WAS STILL UNABLE TO ASPIRATE. THEY THEN STATED THAT THEY WOULD LIKE TO PUSH THROUGH WITH SALINE TO SEE IF THEY COULD DISLODGE ANY OCCLUSION. THE REP RECOMMENDED TO THE HCP NOT DO THIS, AS THERE WAS STILL POTENTIALLY OLD MEDICATION IN THE CATHETER. THE REP TOLD THE HCP THAT THE PATIENT PREVIOUSLY HAD MORPHINE 25 MG/ML IN THEIR PUMP, AND THAT PUSHING THROUGH WOUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679534 ↗
• MalfunctionJun 3, 2026Electromagnetic Interference; Pumping Stopped

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING BUPIVACAINE (15MG/ML AT .899MG/DAY) AND MORPHINE (20MG/ML AT 1.199MG/DAY) VIA AN IMPLANTABLE INFUSION PUMP FOR SPINAL PAIN INDICATIONS FOR USE. IT WAS REPORTED ON THE PATIENT'S PUMP LOGS/SESSION REPORT THAT THERE WAS A PUMP MOTOR STALL (B)(6) 2026 AT 10:11AM WITH A SUBSEQUENT RECOVERY THE SAME DAY AT 10:43AM. THERE WAS ANOTHER PUMP MOTOR STALL NOTED (B)(6) 2026 AT 2:34PM WITH A SUBSEQUENT RECOVERY THE SAME DAY AT 2:54PM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375269 ↗
• MalfunctionMar 2, 2026Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTED PUMP SYSTEM FOR NON-MALIGNANT PAIN. THE PUMP WAS USED TO DELIVER AN UNKNOWN DRUG, DILAUDID (HYDROMORPHONE) AND CLONIDINE. DOSE AND CONCENTRATION INFORMATION WAS NOT REPORTED. IT WAS REPORTED THAT, RIGHT AFTER THE PATIENT RECEIVED THEIR HANDSET, THE PATIENT NOTICED THAT THEIR PUMP TIME WAS INCORRECT, BUT THE TIME ON THE HANDSET WAS CORRECT. THE PATIENT ATTEMPTED TO CORRECT THE PUMP TIME WITH THEIR DOCTOR, BUT THE REPORTER DID NOT KNOW IF THEY FIXED IT OR NOT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT WHO REPORTED THAT AFTER CHECKING WITH HIS DOCTOR THAT FILLED HIS PUMP, ADJUSTMENTS WERE MADE, AND EVERYTHING WAS FINE, BUT NOW THE PART THAT COMMUNICATED WITH THE PUMP WAS SLOW AND IT WOULDN¿T CONNECT WITH THE PUMP AT TIMES IT TOOK SEVERAL MINUTES TO GET A BOLUS. THE ¿COUNTER¿ LOSES CONTACT WHEN TRYING TO USE. THE PATIENT ALSO INCLUDED THAT PER THE DOCTOR, THE PUMP TIME WAS ¿NOT OFF TIME¿. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT WHO REPORTED THAT EVERYTHING HAS DOUBLED WHEN ATTEMPTING A BOLUS AND GOES THROUGH 3 DIFFERENT TIMES TO TALK TO THE PUMP. THE PATIENT REPORTED IT WOULD JUST SPIN UNTIL IT DELIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24486290 ↗
• MalfunctionFeb 25, 2026Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING MORPHINE VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS CHRONIC LOW BACK PAIN AND NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT THEY WERE HAVING AN ISSUE WITH GETTING THE PTM (PERSONAL THERAPY MANAGER) TO DELIVER A BOLUS. THE PATIENT STATED THAT WHEN THEY ¿PRESS OR SCAN UP TO GET IT TO GO TO WHERE IT SAYS BOLUS WITH AN ARROW, ALL IT DOES IS SAY 0% AND SAYS CONNECTING TO PUMP, BUT IT'S NOT CONNECTING¿. THE PATIENT STATED THAT THEY HAD CHARGED BOTH DEVICES. THE AGENT ASSISTED THE PATIENT IN CLOSING THE MYPTM APP AND REOPENING IT AND THE PATIENT CONFIRMED THEY WERE ABLE TO SUCCESSFULLY CONNECT TO THEIR PUMP AND BOLUS. WHILE ON THE CALL, THE PATIENT MENTIONED THAT THEY HAD HAD THIS ISSUE IN THE PAST, BUT IT HADN¿T HAPPENED WHERE THEY HADN'T BEEN ABLE TO FINISH AND CONNECT. THE PATIENT STATED THAT IT ¿USUALLY SCANS AND STOPS AT 91%¿. THE PATIENT ALSO MENTIONED THEY SOMETIMES HAD TROUBLE GETTING THE HANDSET TO CONNECT TO THE COMMUNICATOR. THE AGENT REVIEWED CONSIDERATIONS AND REDIRECTED THE PATIENT TO CLOSE THE APP WHEN THEY ARE DONE USING IT AND THE PATIENT WAS GOING TO MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24440249 ↗
• MalfunctionFeb 24, 2026Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER AND A CONSUMER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING AN UNKNOWN MEDICATION VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT IT TOOK A LONG TIME TO GET A BOLUS, AND THE APP GOT STUCK AT 90%. PER THE PATIENT, IT HAD BEEN HAPPENING FOR A LONG TIME, BUT THEY WERE NOT ABLE TO GIVE A SPECIFIC DATE AS TO WHEN THEY NOTICED IT. THE AGENT REVIEWED HOW TO CLEAR THE PDS (PATIENT DATA SERVICES) DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433652 ↗
• MalfunctionJan 12, 2026Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. THE HCP REPORTED THAT PATIENT'S PERSONAL THERAPY MANAGER (PTM) WAS RUNNING SLOW AND INQUIRED ABOUT CLEARING THE DATA FROM THE HANDSET. THE PATIENT STATED THAT THEY PREVIOUSLY HAD EXPERIENCED THE SAME ISSUE. AGENT REVIEWED STEPS TO CLEAR DATA FROM THE HANDSET. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036197 ↗
• MalfunctionDec 11, 2025Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR PAIN. IT WAS REPORTED THAT DURING NORMAL BATTERY DEPLETION THE CATHETER WAS REVISED. THE REASON FOR CATHETER REISION WAS DUE TO THE END BEING WORN AND IT WAS CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778591 ↗
• InjuryDec 8, 2025Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING THE PATIENT RECEIVING MORPHINE (.2502MG/DAY AT 4.5MG/ML) VIA AN IMPLANTABLE INFUSION PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT DURING A PUMP REPLACEMENT, THE CATHETER WAS FOUND TO BE BROKEN SO THE HCP OPTED TO REPLACE IT WITH A NEW ONE. THE HCP ASKED THE REP TO CALCULATE A DILUTION TO THE MEDICATION SO THE REP CONTACTED TECHNICAL SERVICES BUT THE HCP WENT THROUGH THE MATH WITH THE REP AND THEY RESOLVED IT ON THEIR OWN. THERE WERE NO ISSUES, SIGNS, OR SYMPTOMS, AND NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS KNOWN TO HAVE CONTRIBUTED TO THE EVENT. NO DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED, AS THE HCP VISUALLY IDENTIFIED THE BREAK IN THE CATHETER. THE CATHETER WAS REPLACED WITH A NEW ONE, THE BROKEN CATHETER WAS DISCARDED, AND THE HCP ASSISTED THE REP WITH THE CALCULATION AND NEW TABLET SETTINGS. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742829 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE PUMP CONTAINING SALINE FOR SPINAL PAIN AND FAILED BACK SURGERY SYNDROME. PATIENT MENTIONED THEY HAVEN'T HAD MEDICATION SINCE 2022. PATIENT STATED THAT IN 2022 THEIR HEALTHCARE PROVIDER (HCP) STOPPED TAKING CARE OF THEM AND FILLED THEIR PUMP WITH SALINE. PATIENT MENTIONED THEY HAVE TRIED TO CONTACT THE CLINIC WHO IMPLANTED IT, BUT STATED THAT THEY NO LONGER CAN SEE THE PATIENT, AND THEIR HCP WAS NO LONGER ASSOCIATED THERE. PATIENT STATED THAT THEY WERE IN THE HOSPITAL OVER THE PAST SUMMER AND THEY HAD MRSA ON L5 AND L6 WHERE PUMP 'LEAD' WAS LOCATED. PATIENT SAID THAT THEY ALMOST DIED FROM IT. AGENT REVIEWED INFORMATION AND EMAILED PHYSICIAN LISTING.

  Patient problems: Bacterial Infection

  MAUDE report 23652850 ↗
• MalfunctionNov 17, 2025Communication or Transmission Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIV ING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. IT WAS REPORTED THAT WHEN THE PATIENT'S PUMP IS READ THE PROGRESS BAR GETS TO 99% AND THEN JUST STALLS. THEY HAD TRIED IT MULTIPLE TIMES WITH THE SAME RESULT. THE HEALTHCARE PROVIDER WAS ABLE TO READ OTHER PATIENTS WITH NO ISSUES. REQUESTED TABLET LOGS FOR THE SESSIONS WHEN THEY TRIED TO READ THIS SPECIFIC PATIENT'S PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575988 ↗
• MalfunctionOct 24, 2025Improper or Incorrect Procedure or Method; Battery Problem; Improper or Incorrect Procedure or Method; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING MORPHINE DRUG VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN INDICATIONS USE. IT WAS REPORTED THAT HER PUMP DIED LAST (B)(6). THE PATIENT STATED THAT THEY DID NOT EXPECT THE PUMP TO DIE THAN AND SHE HAD TO GO TO THE EMERGENCY ROOM (ER) FOR ORAL MEDICATION. THE PATIENT STATED THAT HER WORK COMP HAS BEEN TRYING TO FIND A SURGEON OR DOCTOR TO REPLACE THE PUMP. THE AGENT ASKED IF THERE IS SALINE IN THE PUMP AND THE PATIENT STATED THAT THEY ALWAYS DRAW OUT THE EXCESS AND PUT IN THE NEW SO THERE WAS SOMETHING IN THERE, BUT THEY SAID THE MOTOR DIED AND AGENT ADVISED THE PUMP WAS AT 7 YEARS. THE AGENT HAD A HARD TIME UNDERSTANDING AND FOLLOWING THE PATIENT. THE PATIENT MENTIONED THAT THEY WERE SUPPOSED TO GET THE PUMP REFILLED ON MONDAY, BUT THEY COULD NOT TELL HER HOW MUCH IT WAS IN THERE SINCE THEY ALWAYS DRAW IT OUT WITH THE DOCTOR. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. THE AGENT SENT EMAIL TO THE MEDTRONIC REPS IN THE AREA. THE PATIENT MENTIONED THERE IS A LOT OF MEDICATIONS THAT SHE COULD NOT TAKE SUCH AS FENTANYL. SHE TAKES EXTENDED RELIEF MORPHINE CURRENTLY, HOWEVER, DID NOT DO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23382820 ↗
• InjuryOct 20, 2025Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT DURING PUMP REPLACEMENT IT WAS FOUND THAT THE CATHETER WOULD NOT ASPIRATE SO PHYSICIAN REPLACED WITH A NEW CATHETER. DUE TO CATHETER NOT ASPIRATING, PHYSICIAN EXPLANTED A PORTION OF THE CATHETER AND LEFT A PORTION TIED OFF/ INACTIVE IN THE PATIENT. PATIENT NOTED NO SYMPTOMS. IT WAS REPORTED THAT THE ISSUE RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336566 ↗
• MalfunctionOct 15, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM THE PATIENT PREVIOUSLY RECEIVING INTRATHECAL BUPIVACAINE AND MORPHINE (UNKNOWN) VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. THE PATIENT REPORTED THAT HIS PUMP HAD BEEN EMPTY SINCE SEPTEMBER. PATIENT STATED THAT THEY HAD ASKED THE HEALTHCARE PROVIDER TO TAKE THE PUMP OUT OR PUT SOMETHING NON NARCOTIC IN THE PUMP TO HELP WITH THE PAIN BUT NO ONE WOULD DO IT. PATIENT MENTIONED THAT THEY USED TO HAVE MORPHINE, BUPIVACAINE. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AGENT SENT THE PATIENT A PHYSICIAN LISTING.

  Patient problems: Pain

  MAUDE report 23301531 ↗
• InjuryOct 15, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL DILAUDID (HYDROMORPHONE) 2 MG/ML AT 0.25 MG/DAY VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE CATHETER HAD MIGRATED OUT OF THE INTRATHECAL SPACE. THE HCP INITIALLY DID NOT USE MEDTRONIC ANCHORS FOR CATHETER REPLACEMENT. THEY REPLACED THE SPINAL PORTION OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23283398 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN IMPLANTED INFUSION PUMP. THE PUMP WAS USED TO DELIVER UNKNOWN MORPHINE 1MG/ML AT 0.9MG/DAY. IT WAS REPORTED THAT, DURING A ROUTINE ELECTIVE REPLACEMENT INDICATOR (ERI) PUMP REPLACEMENT, THE SURGEON THOUGHT THE CATHETER "LOOKED A LITTLE COMPROMISED" SO HE REPLACED THE PUMP SEGMENT AND REMOVED 25CM OF THE SPINAL SEGMENT. ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE NOT APPLICABLE; THE CATHETER WAS TWISTED UNDER THE PUMP. IN REGARDS TO DIAGNOSTICS/TROUBLESHOOTING PERFORMED, THE SURGEON WAS ABLE TO ASPIRATE JUST FINE FROM THE CATHETER ACCESS PORT (CAP). NO OTHER TROUBLESHOOTING WAS PERFORMED. THE NEW CATHETER PIECE ASPIRATED GREAT. AT THE TIME OF THIS REPORT, THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23283194 ↗
• MalfunctionOct 15, 2025Device Alarm System; Insufficient Device Problem Information; Device Alarm System; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING DILAUDID VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN. THE PATIENT¿S REPRESENTATIVE REPORTED THAT THE PUMP HAD BEEN BEEPING EVERY 15-30 MINUTES. THE CALLER STATED THAT THEY WENT TO THE DOCTOR TO GET THE PUMP FILLED AND THOUGHT THE PUMP WAS BEEPING BECAUSE THEY WERE AT THE END OF THEIR MEDICATION, BUT THE PUMP WAS STILL BEEPING AFTER THE REFILL. THE CALLER STATED THAT THE PATIENT HAD A PTM (PERSONAL THERAPY MANAGER) BUT DIDN¿T USE IT BECAUSE IT DIDN'T HELP THEM. THE AGENT REVIEWED CONSIDERATIONS AND REDIRECTED THE CALLER AND PATIENT TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276610 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING AN UNKNOWN MEDICATION VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN. THE PATIENT¿S REPRESENTATIVE REPORTED THE PATIENT HAD THEIR PUMP REPLACED DUE TO AN ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23093389 ↗
• MalfunctionAug 28, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) INDICATED THAT THE PREVIOUSLY REPORTED PROCEDURE WAS A PUMP REPLACEMENT FOR PUMP END OF LIFE. THE INABILITY TO CLEAR THE CATHETER OCCURRED THROUGH THE CATHETER ACCESS PORT (CAP) WHILE THE PUMP WAS CONNECTED. THE CAUSE OF THE INABILITY TO CLEAR THE CATHETER WAS NOT DETERMINED. IN REGARDS TO ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE ISSUE, THERE WERE MULTIPLE ATTEMPTED TO CLEAR THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912847 ↗
• MalfunctionAug 28, 2025Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT RECEIVING LIORESAL 2000MCG/ML VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS INTRACTABLE SPASTICITY. THE HEALTHCARE PROVIDER REPORTED THAT THE PATIENT REQUESTED TO PERMANENTLY SHUT DOWN THE PUMP DUE TO CATHETER MALFUNCTION, PUMP NEARING EOS (END OF SERVICE) IN SEPTEMBER AND THE PATIENT FEELING NO BETTER THAN BEFORE THEY STARTED THERAPY. THE HEALTHCARE PROVIDER WAS PROVIDED WITH PASSCODE TO SHUT DOWN THE PUMP.

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

  MAUDE report 22910561 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING INTRATHECAL CLONIDINE AND DILAUDID VIA AN IMPLANTED PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD NOT HAD MEDICATION IN THE PUMP SINCE ABOUT 2021-2022 BECAUSE THEY WERE OVERDOSED AT THAT TIME. IT WAS REPORTED THE PATIENT WAS IN ACUTE CARE FACILITY FOR FIVE MONTHS AND HAD TO RELEARN HOW TO WALK BECAUSE OF THE OVERDOSE. THE PATIENT ALSO MENTIONED THEY FOUND OUT THEY WERE ALLERGIC TO MORPHINE BECAUSE THAT WAS THE MEDICATION PUT IN THE FIRST PUMP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22861649 ↗
• MalfunctionAug 19, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING DILAUDID AND THREE OTHER UNKNOWN DRUGS VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PUMP HAD BEEN EMPTY NOW FOR THREE YEARS AND THEY HAD PUT UP WITH THE PAIN. THEY NO LONGER WANTED ANYTHING TO DO WITH THE PUMP AND THEY WANTED IT REMOVED. THEY WOULD NOT GO BACK TO THE HEALTHCARE PROVIDER (HCP) BECAUSE OF HOW THEY WERE TREATED. AGENT EMAILED HCP LISTINGS.

  Patient problems: Pain

  MAUDE report 22843088 ↗
• InjuryAug 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS RECEIVING MORPHINE DRUG AND BUPIVACAINE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PUMP WAS CAUSING DAMAGE TO THE PATIENT'S SPINAL CORD. THE PATIENT REPRESENTATIVE (REP) STATED THAT THE PATIENT WAS NO LONGER USING THE PUMP, AND THEY WERE TRYING TO FIND A PHYSICIAN TO TAKE THE PUMP OUT. THE PUMP HAS NOT BEEN IN USE FOR A FEW YEARS. THE REP INQUIRED ABOUT A RECALL IN 2019. THE AGENT SENT PHYSICIAN LISTINGS TO THE REP. THE PATIENT HAD MORHPINE 6.0 MG IN THE PUMP.

  Patient problems: Spinal Cord Injury

  MAUDE report 22693293 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PUMP REACHED EOS (END OF SERVICE) AND WAS NOT REPLACED IN TIME DUE TO MISCOMMUNICATION. PER THE REPORTER, THE PATIENT WENT INTO WITHDRAWAL. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 22-JUL-2025 WHO REPORTED THAT THEY HAD TO BE HOSPITALIZED TWICE OVER 3 WEEKS. THE PATIENT WAS GIVEN PAIN MEDS AND PUT ON A PAIN PUMP BESIDE THE BED. THE PATIENT WAS PUT ON 12HR RELEASE MORPHINE AND 20MG OXYCODONE EVERY 3 HOURS. THE PHYSICIAN TOOK AWAY THE MORPHINE AND ONLY GAVE THE PATIENT OXYCODONE EVERY 6 HOURS, SO PER THE PATIENT THEY SUFFERED WITH PAIN AND WITHDRAWAL EVER SINCE. THE PATIENT¿S PUMP WAS REPLACED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Pain

  MAUDE report 22629690 ↗
• InjuryJul 18, 2025Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIV ING DILAUDID (HYDROMORPHONE) AT 2.4 VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO ACCESS THE CATHETER ACCESS PORT (CAP) AND PULL BACK CEREBROSPINAL FLUID (CSF) BUT WAS UNABLE TO. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PHYSICIAN DECIDED TO REPLACE SPINAL SEGMENT. THE CATHETER AND THE OLD PUMP WERE SENT TO HOSPITAL PATHOLOGY LAB PER HOSPITAL PROTOCOL. THE ISSUE WAS RESOLVED. THE HEALTHCARE PROVIDER (HCP) HAS NO FURTHER INFORMATION FOR MEDTRONIC. THE PATIENT REPORTED NO SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22539250 ↗

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-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-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-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-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
• Z-2276-2009 · Jul 1, 2009 · Terminated
  Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed II Pump is supplied in 20 m

…and 24 more.