SYNCHROMED ® II 8637-20 (UDI 00643169100831)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,084 adverse event reports that list this exact device (DI 00643169100831), received between Apr 23, 2014 and Sep 22, 2026 — classified as 4 deaths, 1,958 injuries, 1,122 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (452 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 16, 2026.

Recalls naming this device

1. Nov 13, 2023Open, 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 3,084 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient receiving Clonidine, Dilaudid, and Bupivacaine via an implantable infusion pump for non-malignant pain indications for use. It was reported that their pump was replaced in 2019 due to infection. The patient stated that they had had a pump for a long time and believed it had been replaced about 4 to 5 times, with the last replacement occurring because of infection.

  Patient problems: Unspecified Infection

  MAUDE report 50858246 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE DOCTOR REMOVED THE PUMP IN (B)(6) 2024 BECAUSE FOR ALMOST 8 MONTHS THE PATIENT HAD WHAT SOUNDED LIKE THE PATIENT CALLED "SEVERE RATINITIS OF THE SPINE.".

  Patient problems: Insufficient Information

  MAUDE report 25584283 ↗
• MalfunctionJun 3, 2026Device Alarm System; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT STATED THEY NEED TO GET THE PUMP TAKEN OUT. THE PUMP HAD BEEN OFF SINCE PROBABLY IN 2013, AND IT WAS PUSHING ON AND UP UNDER THEIR RIBS. IT HAD MIGRATED. THE PUMP HAD BEEN ALARMING, BUT THEY HADN'T HEARD THE ALARM IN A WHILE. THE PATIENT ASKED FOR A HEALTHCARE PROVIDER (HCP) LISTING TO REMOVE THE PUMP. THE AGENT EMAILED AND MAILED THE PHYSICIAN LISTING TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 25377231 ↗
• MalfunctionMay 29, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP. THE PATIENT REPORTED THAT HER PUMP BATTERY WAS NOT WORKING. AGENT OFFERED PATIENT TECHNICAL SERVICES TO CHECK IT BUT PATIENT REFUSED TO BE CONNECTED SINCE SHE WOULD BE HAVING MAGNETIC RESONANCE IMAGING (MRI) SOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333092 ↗
• InjuryMar 18, 2026Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PUMP WAS TURNED OFF AND THERE WAS NO MEDICATION IN THE PUMP. THE PUMP HAD MOVED AND PRESSED ON THE PATIENT'S PELVIS WHEN THE PATIENT SAT CERTAIN WAYS. THE HEALTHCARE PROVIDER AGREED TO DO THE SURGERY AND TAKE OUT THE OTHER PUMP AND PUT IN A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630146 ↗
• MalfunctionFeb 25, 2026Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM THE PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. THE PATIENT MENTIONED THAT THE HANDSET ALWAYS GETS STUCK AT 91%. AGENT REVIEWED INFORMATION AND ASSISTED PATIENT WITH CLEARING DATA ON THE HANDSET. PATIENT WOULD MONITOR LAG ISSUE AND CALL BACK IF FURTHER ASSISTANCE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444359 ↗
• InjuryFeb 2, 2026Misconnection

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING AN UNKNOWN MEDICATION VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS INTRACTABLE SPASTICITY. THE PATIENT REPORTED THAT THE CATHETER WAS NOT CONNECTED SO MEDICINE WAS GOING INTO THEIR BODY AND THEN ANOTHER DOCTOR FIXED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232232 ↗
• InjuryNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIV ING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE SITUATION WAS UNKNOWN, THE COMPANY REPRESENTATIVE WAS NOT NOTIFIED WHEN THE PREVIOUS SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE. IT WAS UNKNOWN IF EXTERNAL FACTORS WERE INVOLVED AND UNKNOWN IF TROUBLESHOOTING WAS PERFORMED. A NEW SYSTEM WAS IMPLANTED TODAY AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659554 ↗
• MalfunctionOct 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  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 HAD MAGNETIC RESONANCE IMAGING AND THEY FOUND OUT THAT THE PUMP HAD MOVED. THEY ALSO HAD A COMPUTED TOMOGRAPHY SCAN AND X-RAY. AGENT REDIRECTED THEM TO THE HEALTHCARE PROVIDER FOR FURTHER ASSISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383506 ↗
• InjuryOct 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WITH AN IMPLANTABLE PUMP USED FOR SPINAL PAIN. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER REMOVED THE PUMP ON (B)(6) 2021. IT WAS REPORTED THAT THE OPERATIVE NOTES INDICATED THAT THE PUMP WAS "NON-FUNCTIONING." THE HEALTHCARE PROVIDER STATED THAT THE OPERATIVE REPORT ALSO INDICATED THAT THE CATHETER WAS "CUT AND TIED OFF" SO THEY DON'T BELIEVE THE CATHETER WAS FULLY EXPLANTED HOWEVER THE PATIENT STATED THAT EVERYTHING FROM THE PUMP SYSTEM WAS REMOVED. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380132 ↗
• InjuryOct 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING INTRATHECAL DILAUDID (HYDROMORPHONE) VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN AND CHRONIC LOW BACK PAIN. THE PATIENT STATED THEY HAD TO HAVE THE PUMP "REDONE" IN 2020 BECAUSE IT CAME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23326290 ↗
• InjurySep 16, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION WAS PROVIDED FROM A HEALTHCARE PROVIDER STATED THAT THE CAUSE OF UNABLE TO ASPIRATE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063586 ↗
• InjurySep 2, 2025Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Device Problem Information; Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE PUMP INFUSING AN UNKNOWN DRUG. IT WAS REPORTED THAT THE PATIENT STATED THEY HAD THE PUMP IMPLANTED A LONG TIME AGO, THEN STATED IN 2014. THE PATIENT DID NOT HAVE THEIR ID CARD AND NEVER GOT ONE. THE PATIENT STATED THEY SHOULD HAVE HAD THE PUMP EXPLANTED A LONG TIME AGO BECAUSE THE PUMP HASN'T HAD MEDICATION IN IT FOR 2 YEARS AND 'IT REALLY MESSED ME UP.' THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

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

  MAUDE report 22935967 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 FROM THE FACILITY ON (B)(6) 2025, THE PUMP AND CATHETER WERE REMOVED ON (B)(6) 2018 BECAUSE PATIENT HAD PAIN ON THE PART WHERE THE PUMP WAS IMPLANTED.

  Patient problems: Pain

  MAUDE report 22926492 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP. THE PATIENT'S PUMP [SYSTEM] WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22925923 ↗
• InjuryAug 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY/CEREBRAL PALSY INDICATIONS FOR USE. THE PATIENT REPRESENTATIVE (REP) REPORTED THAT THE PUMP WAS REMOVED IN 2017. THE REP STATED THAT THE PATIENT SUFFERED FROM AN INFECTION WHICH COMPROMISED THE PUMP DEVICE. THE PUMP HAD TO BE REMOVED IN AN EMERGENCY. THEY DID NOT REMEMBER WHAT DRUG WAS IN THE PUMP.

  Patient problems: Unspecified Infection

  MAUDE report 22824542 ↗
• MalfunctionAug 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE PATIENT RECEIVING INTRATHECAL HYDROMORPHONE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. THE PATIENT REPORTED THEY WERE IN THE MIDDLE OF A CUSTODY BATTLE WITH HER DAUGHTER AND SON IN LAW AND SHE WAS NOT ABLE TO GET BACK TO (B)(6) TO HAVE THE PUMP FILLED UP. PATIENT STATED THE LAST TIME 2015 THE PUMP MALFUNCTIONED IT BEEPED AND AGGRAVATED THE CRAP OUT OF HER AND THEY HAD TO RESET THE PUMP. PATIENT SAID THE FIRST PUMP MALFUNCTION WAS WHEN THEY WALKED BY SOMETHING AND THE PUMP STARTED BEEPING. PATIENT STATED THEY DID NOT WANT THE PUMP TO ALARM BECAUSE THEY COULD NOT GET BACK TO (B)(6) TO REFILL THE PUMP AND LIKE TO KNOW IF THEY COULD GET SOMEONE TO TURN OFF THE ALARM. AGENT CONFIRMED THE PUMP WAS NOT ALARMING CURRENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715662 ↗
• InjuryJul 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED FROM THE PATIENT VIA THE COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT PER A PHONE CALL TO PATIENT ON 07/09/2025, PUMP WITH SERIAL NUMBER (B)(6) WAS REMOVED DUE TO LEAKING. THEY DID NOT HAVE ANY FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576356 ↗
• MalfunctionMay 27, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS RECEIVING MORPHINE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT'S PUMP WENT DRY 'LIKE 5 YEARS AGO' AND THE PATIENT 'WENT REALLY BAD' AND HAD WITHDRAWALS. CURRENTLY, THEY WERE TRYING TO FIND A NEW HEALTHCARE PROVIDER IN THE AREA THAT WOULD FILL THE PUMP WITH SALINE AS THEIR PUMP WAS GOING TO RUN DRY ON (B)(6) 2025, BUT THEY HAD NOT BEEN ABLE TO FIND ANYONE YET. AGENT EMAILED PHYSICIAN LISTINGS.

  Patient problems: Insufficient Information

  MAUDE report 22090679 ↗
• InjuryApr 30, 2025Obstruction of Flow; Obstruction of Flow

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PUMP WAS REPLACED ON (B)(6) 2025 HOWEVER, SHE HAD NOT USED HER PUMP SINCE 2017. UPON REPLACING THE PUMP, AN ATTEMPT TO ASPIRATE THE CATHETER WAS MADE, HOWEVER, THE CATHETER WAS NOT PATENT AND NEEDED TO BE REPLACED. THERE WERE NO KNOWN ENVI RONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS RESOLVED. THE HEALTHCARE PROVIDER (HCP) HAS NO FURTHER INFORMATION FOR MEDTRONIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939661 ↗
• MalfunctionApr 3, 2025Migration or Expulsion of Device; Insufficient Flow or Under Infusion; Positioning Problem; Migration or Expulsion of Device; Insufficient Flow or Under Infusion; Positioning Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT RECEIVING FENTANYL AND BACLOFEN VIA IMPLANTABLE PUMP. THE INDICATION USE WAS SPINAL PAIN. IT WAS REPORTED THAT THEIR PUMP HAS BEEN EMPTY FOR OVER TWO YEARS AND THEY WANTED TO KNOW IF IT WAS POSSIBLE TO START REFILLING IT. THE PATIENT STATED THAT THEIR FIRST DOCTOR, WHO IMPLANTED THE PUMP, MOVED TO A DIFFERENT PRACTICE 300 MILES AWAY AND DIED 3 MONTHS LATER, SO THEY GOT WITH ANOTHER DOCTOR, BUT THE NEW DOCTOR CLOSED THEIR PRACTICE. WHEN THE AGENT ATTEMPTED TO CLARIFY IF THERAPY WAS ABANDONED, PATIENT INTERRUPTED AGENT TO ASK ANOTHER QUESTION AND DID NOT CLARIFY. THE PATIENT STATED THAT THE PUMP 'IS SENDING OUT A CRITICAL ALARM,' AND STATED 'I (THE PUMP) SOUNDS LIKE A SCHOOL BUS OR A POLICE CAR,' IT WAS CONFIRMED THAT A DUAL TONE ALARM WAS THE ALARM THEY HEAR. THE PATIENT MENTIONED THAT THEY HAVE LOST A LOT OF WEIGHT, AND THE PUMP NOW SHIFTS AND HITS WHAT THEY THINK THEIR SCIATIC NERVE BAD. THE PATIENT CONFIRMED THAT THEY ASSUME IT WAS A SCIATIC NERVE THAT THE PUMP WAS HITTING BECAUSE WHEN IT (THE PUMP) 'DROPS' ON THE AREA, THEY CAN HARDLY WALK, AND IT SAT ON A NERVE WHICH CAUSED THEM A LOT OF HIP PAIN. THE PATIENT IN

  Patient problems: Ambulation or Postural Difficulties; Pain; Weight Changes

  MAUDE report 21759627 ↗
• InjuryMar 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT PREVIOUSLY RECEIVING INTRATHECAL DILAUDID (HYDROMORPHONE) AND CURRENTLY SALINE AT UNKNOWN CONCENTRATION /DOSES VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT THEY WERE HAVING MAGNETIC RESONANCE IMAGING (MRI) OF THE LUMBAR AND THORACIC AND LIKE TO KNOW THE MRI GUIDELINES. PATIENT REPORTED THEY STOPPED USING THE PUMP 3YRS AGO BECAUSE THE PUMP WAS NOT HELPING THEM AND MESSED UP THEIR SEX LIFE. PATIENT STATED THEY OVERDOSED (OD) TWICE AND HAD TO GET NARCAN ONCE. PATIENT STATED DOCTOR REFILL THE PUMP WITH SALINE AND THE PUMP HAD BEEN ALARMING SINCE THEN. PATIENT STATED THEY DID NOT SEE DOCTOR ANY LONGER AND LIKE TO GET DOCTOR LISTING. PATIENT STATED THEY DID NOT WANT TO HAVE THE PUMP ANY LONGER. PATIENT STATED THEY WENT INTO DOCTOR'S OFFICE AND ASKED HIM TO STOP REFILLING THE PUMP SO THEY DID NOT GET IT FILLED ANYMORE.

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

  MAUDE report 21575284 ↗
• MalfunctionFeb 25, 2025No Audible Alarm; Electromagnetic Interference; No Audible Alarm; Electromagnetic Interference

  ON 2025-01-21, INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTED INFUSION PUMP FOR MALIGNANT PAIN. AT THE TIME OF THIS REPORT, THE PUMP WAS USED TO DELIVER PRIALT (ZICONOTIDE). DOSE AND CONCENTRATION INFORMATION WAS NOT REPORTED. PUMP DRUG INFORMATION AT THE TIME OF THE EVENT WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT WAS HARD OF HEARING AND, WHEN A PUMP ALARM WENT OFF, THEY COULD NOT HEAR IT. THE PATIENT WAS NOT SURE WHEN THIS OCCURRED. ON 2025-02-14, ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT THE DATE THAT THE PUMP ALARM OCCURRED WAS NOT KNOWN. IT WAS UNKNOWN WHAT CIRCUMSTANCES LED TO THE PUMP ALARM. PER THE PATIENT "IT WAS AT LEAST 10 YEARS AGO IF NOT LONGER" AND THEY THOUGHT IT WAS A STALL ALARM FROM MAGNETIC RESONANCE IMAGING (MRI). IT WAS NOT KNOWN WHAT TYPE OF PUMP ALARM OCCURRED. IT WAS NOT KNOWN WHAT STEPS WERE TAKEN TO RESOLVE THE PUMP ALARM. PER THE PATIENT, IF IT WAS A STALL ALARM, IT WAS RESOLVED BY A MANUFACTURER REPRESENTATIVE (REP) AFTER THE MRI. THE CURRENT STATUS OF THE DEVICE WAS ASKED BUT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462172 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM A CONSUMER (CON) REPORTED THAT HIS SYSTEM THAT HAD BEEN IMPLANTED ON (B)(6)2015 HAD BEEN EXPLANTED AT THE END OF 2015 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20923228 ↗
• MalfunctionDec 9, 2024Migration or Expulsion of Device; Insufficient Flow or Under Infusion; Insufficient Device Problem Information; Migration or Expulsion of Device; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND PERIPHERAL NEUROPATHY. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS PATIENT STATED THEY RECEIVED A LETTER FROM PRS DATE (B)(6) 2024, TO UPDATE THEIR INFORMATION AND THE NUMBER ON THE LETTER WAS FOR PATIENT SERVICES. THE PATIENT THEN STATED THEY HAD A SECOND PUMP PUT IN ON (B)(6) 2015 BUT THE PUMP NEVER WORKED FOR THEM, SO THEY LET THE PUMP RUN OUT OF MEDICATION TO PROVE IT TO THE DOCTOR BECAUSE HE DIDN'T BELIEVE THE PATIENT AND THEY DID NOT FEEL ANY DIFFERENT AS FAR AS PAIN. THE PATIENT STATED THEY SAID (AT AN APPT) IT WENT DRY A COUPLE WEEKS AGO AND TOLD THE DOCTOR YOU DON'T HAVE TO FILL IT. THE PATIENT STATED THAT THE DOCTOR WAS SHOCKED AND HE TOLD THEM THAT THEY WOULD BE IN THE EMERGENCY ROOM (ER) AND WOULD BE SCREAMING IN PAIN, BUT, THEY WERE IN SO MUCH AGONY THEY WENT TO JUST PILLS. THE DOCTOR TOLD THE PATIENT THEY WERE 1 IN A MILLION BUT THE PATIENT STATED THEY DOUBTED THAT. THE PATIENT STATED IT HAD BEEN 10 YEARS NOW AND THE PUMP WAS STILL IMPLANTED AND IT REACHED ITS END OF SERVICE (EOS} LIKE 4-5 YEARS AGO. THE PATIENT MENTIONED THEY TOLD THE DOCTOR THAT THE PUMP WAS NOT WORKING

  Patient problems: Insufficient Information; Pain

  MAUDE report 20877833 ↗

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-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
• 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.