SYNCHROMED ® II 8637-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,119 adverse event reports that list this exact device (DI 00643169100824), received between Jul 14, 2014 and Aug 12, 2026 — classified as 6 deaths, 2,816 injuries, 1,297 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (839 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. How this data works · Data updated Oct 13, 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-0615-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,119 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Pumping Stopped

  Information was received from a patient who was receiving Fentanyl via an implantable pump for non-malignant pain. It was reported that the patient mentioned that they had their pump replaced 4-5 years ago (b)(6) 2021 because the pump motor was "hanging up" and they had to put a new pump in.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227167 ↗
• MalfunctionMay 20, 2026Pumping Stopped

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING INTRATHECAL MORPHINE, FENTANYL, CLONIDINE AND BUPIVACAINE VIA AN IMPLANTABLE PUMP FOR MALIGNANT PAIN. THE PATIENT STATED TWO HOURS AFTER THE IMPLANT, SHE WAS BACK IN THE EMERGENCY ROOM BECAUSE THE PUMP STALLED IMMEDIATELY. THE PATIENT STATED SHE BEGGED THEM TO REMOVE THE PUMP BUT THEY WOULDN'T.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230227 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE REASON FOR THE FOR THE CALL WAS TO GET DEVICE REGISTRATION INFORMATION. THE CALLER INDICATED THAT THE PATIENT HAD AN ABANDONED LEAD IN THE SPINAL COLUMN BASED ON X-RAYS. THE CALLER DID NOT KNOW ANY OTHER INFORMATION ABOUT THE DEVICE OR IF IT WAS A MEDTRONIC DEVICE. DURING THE CALL THE CALLER SPECULATED THAT WHAT THEY THOUGHT WAS A LEAD MAY BE A CATHETER. TECHNICAL SERVICES CREATED THE CASE BECAUSE THE CALLER REPORTED AN ABANDONED LEAD. THE CALLER DID NOT HAVE ANY OTHER DETAILS ABOUT THE DEVICE OR A POTENTIAL ISSUE THAT RESULTED IN THE COMPONENT BEING ABANDONED. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECHNICAL SERVICES REVIEWED REGISTRATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24955136 ↗
• InjuryMar 20, 2026Adverse 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. IT WAS REPORTED THAT THE CALLER MENTIONED THAT ABOUT 2.5 YEARS AGO SOMEONE CAME TO THEIR HOUSE TO TAKE THE MEDICATION OUT OF THE PUMP TO PREVENT OVERDOSE. HOWEVER CALLER WAS STILL OVERDOSED. CALLER MENTIONED THAT THE PUMP WAS FILLED WITH SALINE NOW.

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

  MAUDE report 24654202 ↗
• MalfunctionFeb 20, 2026Application Program Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM THE PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP FOR MALIGNANT PAIN. THE PATIENT REPORTED THAT EVERY DAY THEY WERE SEEING SERVICE CODE 156. PATIENT STATED WHEN THEY HAD TO BOLUS THEY HAD A LONG FREEZE AT 90%. AGENT REVIEWED DATA AND ASSISTED THE PATIENT IN DELETING THE DATA. PATIENT WAS ABLE TO CONNECT TO THE PUMP WITH NO LAG. AGENT REVIEWED SERVICE CODE 156. PATIENT WOULD CALL BACK IF THEY NEED FURTHER ASSISTANCE. PATIENT CALLED BACK DAYS LATER AND REPORTED THE 156 ERROR CODE CONTINUED TO APPEAR. PATIENT STATED ON SATURDAY IT TOOK THEM 40 MINUTES TO CONNECT TO THE PUMP. PATIENT WOULD MONITOR AND CALL BACK IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405471 ↗
• MalfunctionJan 30, 2026Fluid/Blood Leak; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE INFUSION PUMP FOR SPINAL PAIN INDICATIONS. IT WAS REPORTED THAT IN 2022 THE PATIENT HAD A PUMP REVISION AND THE HEALTHCARE PROVIDER (HCP) WOKE THEM UP IN SURGERY AND SAID THEY HAD FOUND 'A PUSS IN THEIR POCKET' AND THEY WERE SUPPOSED TO MOVE THE PUMP AWAY FROM THE RIB BUT THE HCP DIDN'T. THE PATIENT STATED THEY HAD 2 DYE STUDIES LEADING UP TO THIS SURGERY THAT CONCLUDED THAT THE CATHETER WAS LEAKING. THE PATIENT STATED 'ALL THEY DID WAS CHANGE THE PUMP' AND SENT THE PATIENT HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Purulent Discharge

  MAUDE report 24226637 ↗
• MalfunctionSep 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING AN INTRATHECAL UNKNOWN MEDICATION VIA AN IMPLANTED PUMP FOR NON-MALIGNANT PAIN AND DEGENERATIVE DISC DISEASE. THE HCP REPORTED A PREVIOUS CASE ABOUT 10 YEARS AGO WHERE THE PUMP WAS OVERDELIVERING DUE TO A "BULGE" IN THE TUBING OF THE PUMP. FURTHER INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23030983 ↗
• InjuryApr 3, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING UNKNOWN INTRATHECAL MEDICATION AT UNKNOWN CONCENTRATION/DOSE VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE LAST TIME THE PUMP WAS REPLACED WAS IN 2022 BECAUSE ONE OF THE STITCHES LET GO AND WAS MOVING AROUND INSIDE THE PATIENT. THE PATIENT REP STATED 3 YEARS AGO ONE OF THE STITCHES LET GO AND THE PUMP WAS MOVING AROUND BUT "THEY FIXED THAT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762152 ↗
• InjuryJan 24, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING UNKNOWN MORPHINE VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WAS SPINAL PAIN INDICATIONS. IT WAS REPORTED THAT THE PATIENT STATED THAT THEY HAVE HAD NOTHING BUT HELL WITH THE PUMP FOR THE LAST 4-5 YEARS. THE PATIENT STATED THAT THE PUMP STOPPED WORKING WHERE IT WAS WORKING INSUFFICIENTLY AND THEY KEPT INCREASING THE DOSAGE UNTIL THEY FINALLY HAD TO HAVE IT REPLACED. THE PATIENT SAID THAT AT THAT TIME THEY DISCOVERED THAT THE TUBING WAS PERFORATED IN THEIR ABDOMEN AND IT WAS DUMPING ALL THAT MORPHINE IN THEIR ABDOMEN INSTEAD OF WHERE IT WAS SUPPOSED TO GO.

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

  MAUDE report 21233363 ↗
• InjuryOct 30, 2024Insufficient Flow or Under Infusion; Insufficient Device Problem Information; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN AND CLONIDINE VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING INCREASING RESIDUALS OVER THE LAST COUPLE OF REFILLS AND INCREASING SPASTICITY. THEY WERE EXPECTING 4.5 ML BUT GOT 10.2 ML. TECHNICAL SERVICES RECOMMENDED PERFORMING A DYE STUDY.

  Patient problems: Muscular Rigidity; Nausea

  MAUDE report 20569571 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING HYDROMORPHONE VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WAS NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT REPORTED THAT IN 2014, THEY HAD THEIR PUMP REPLACED AND CONTRACTED MRSA SO THE PUMP HAD TO BE REMOVED AND THE PATIENT WAS GIVEN PO MEDS FOR PAIN. SIX MONTHS AFTER IT WAS EXPLANTED, A NEW PUMP WAS PLACED ON THE OPPOSITE SIDE OF THE PUMP WITHOUT ISSUE SINCE THEN.

  Patient problems: Unspecified Infection

  MAUDE report 20161221 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT RECEIVING UNKNOWN MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT GOT OVERDOSED AND WERE BRAIN DEAD FOR NINE DAYS. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 19990803 ↗
• InjuryJul 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT RECEIVING UNKNOWN MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT'S PAIN PUMP DID NOT WORK AND THAT IS WHY THEY OPTED TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742056 ↗
• MalfunctionJul 1, 2024Insufficient Flow or Under Infusion; Material Integrity Problem; Insufficient Flow or Under Infusion; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT WAS NO LONGER USING THE PUMP AND BELIEVES IT WAS EMPTY. HE STATED THAT AT SOME POINT THE PATIENT HAD SPINAL SURGERY AND THE CATHETER WAS ACCIDENTALLY CUT. HE THOUGHT THIS WAS WHY THE PATIENT WAS NO LONGER USING THE PUMP. HOWEVER, THE HEALTHCARE PROVIDER (HCP) DID NOT KNOW THE DATE OF THE SPINAL SURGERY OR WHETHER IT WOULD HAVE OCCURRED AFTER THE END OF SERVICE (EOS) DATE OF THE PUMP WHICH WOULD HAVE BEEN IN 2022. THEY WERE DOING THE MAGNETIC RESONANCE IMAGING (MRI) TO RULE OUT CAUDA EQUINA. ADDITIONAL INFORMATION FROM A HEALTHCARE PROVIDER (HCP) STATED THAT THE SPINAL SURGERY WAS NOT RELATED THE PUMP OR THERAPY. THE CATHETER WAS DAMAGED, SO THEY WERE NOT ABLE TO REFILL THE PUMP. THE HCP COULD NOT RECALL THE EVENT DATE SINCE THE SPINAL SURGERY WAS DONE WAS DONE IN ANOTHER CAMPUS. THEY WERE UNABLE TO GIVE ME THE SURGEON¿S CONTACT INFORMATION. IT WAS NOTED THAT THEY HAVE NO OTHER ADDITIONAL INFORMATION FOR THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19647884 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (COMPANY REPRESENTATIVE, CONSUMER) REGARDING A PATIENT RECEIVING UNKNOWN MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THE PATIENT'S PREVIOUS SYSTEM WAS EXPLANTED IN 2019 DUE TO BACTERIAL MENINGITIS.

  Patient problems: Meningitis

  MAUDE report 19359245 ↗
• InjuryMar 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WERE SPINAL PAIN AND LUMBAR RADICULOPATHY. IT WAS REPORTED THAT THE PATIENT STATED 'THE LAST TIME IT FAILED THE PUMP ALARMED - IT DID THIS LIKE 2 YEARS AGO - AND I THINK MARCH 2ND OR 7TH 2 YEARS AGO IS WHEN IT WAS REPLACED.' THE MANUFACTURER'S PATIENT SERVICES SPECIALIST (PSS) DOCUMENTED INFORMATION REPORTED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897165 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT RECEIVING AN UNKNOWN INTRATHECAL MEDICATION VIA AN IMPLANTED PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE PATIENT GOT AN INFECTION AFTER THEIR PUMP WAS IMPLANTED AND SO THEY HAD TO HAVE IT TAKEN OUT AND HAVE A CLEANOUT DONE AND THEN THEY GOT A NEW PUMP IMPLANTED. THE PATIENT STATED THIS HAPPENED 10-15 YEARS AGO AND THAT "IT'S BEEN A LONG TIME".

  Patient problems: Unspecified Infection

  MAUDE report 18750918 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG (UNK AT UNK) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT HAD NEUROPATHIC PAIN AND SPASTICITY THROUGHOUT THE EPIGASTRIC REGION AND MID-TO-UPPER THORACIC AREA AS WELL TO LOWER BACK. THE HCP REPORTED THE RELOCATION OF THE CATHETER TO A MORE CAUDAD LOCATION WAS NOT HELPFUL. THE PATIENT WAS TO HAVE A CATHETER REPLACEMENT WITH A NEW INTRATHECAL CATHETER PLACED AT LEVEL T6 AS ONE LAST CATHETER OPTION. A NON-MEDTRONIC CATHETER WAS USED FOR CATHETER REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Muscular Rigidity; Neuropathy; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18412946 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING UNKNOWN DRUG (UNK AT UNK) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS INFECTED AND NEEDED TO BE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18113500 ↗
• InjuryNov 7, 2023Adverse 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 FENTANYL AND DILAUDID (UNKNOWN CONCENTRATION AND DOSE) VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WANTED THE PUMP REMOVED AND WANTED A NEW HEALTH CARE PROVIDER (HCP) TO WORK WITH. THE PATIENT STATED THAT THEY HAD TO GET THEIR PUMP REPLACED EARLY BECAUSE IT WAS COLLECTING LIQUID. THERE WAS FLUID SHOWING ON THE TOP OF THE PUMP THAT YOU COULD FEEL AND THE PATIENT DESCRIBED IT AS THE WORST TIME OF THEIR LIFE. THE PATIENT FURTHER REPORTED THAT DURING THE REPLACEMENT, THE HCP DECIDED WITHOUT TELLING THE PATIENT TO SWITCH THEM FROM FENTANYL TO DILAUDID AND PUT THEM AT THE LOWEST POSSIBLE AMOUNT BECAUSE HE WANTED THEM TO START ALL OVER AGAIN. THE PATIENT STATED THAT THEY LIKED THE FENTANYL BECAUSE IT WORKED AND THEY DIDN'T HAVE TO GET THE PUMP FILLED OFTEN. THE PATIENT STATED THAT THE PUMP HAD ALWAYS MADE THE DIFFERENCE IN THEM BEING BEDRIDDEN OR NOT. BUT THE HCP WENT TO A DIFFERENT COUNTRY SO THEY HAD A DIFFERENT HCP AND A PHYSICIAN ASSISTANT THAT WAS FILLING THE PUMP. PATIENT SERVICES ATTEMPTED TO GATHER MORE INFORMATION AND CLARIFICATION, BUT PATIENT WOULD NOT PROVIDE INFO W

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Seroma

  MAUDE report 18087447 ↗
• MalfunctionOct 23, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS RECEIVING DILAUDID (HYDROMORPHONE) (6 MG AT 3.96766 MG/DAY), BUPIVACAINE (30 MG AT 19.83832 MG/DAY), AND UNKNOWN BACLOFEN (600 MCG AT 396.76632 MCG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT HAD WORSENING LUMBAR BACK AND LOWER EXTREMITY PAIN. THE IT RATE WAS INCREASED. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THAT THE PATIENT HAD NOT ACHIEVED EFFECTIVE PAIN RELIEF 'FOR MONTHS'. HE REQUESTED TO BEGIN WEANING FROM THE THERAPY.ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THAT THE PATIENT REPORTED WORSENING PAIN DURING A PUMP REFILL VISIT. THERE WAS A RESERVOIR VOLUME DISCREPANCY NOTED: EXPECTED RESERVOIR VOLUME (IRV) 12, ACTUAL RESERVOIR VOLUME (ARV) 38. A CATHETER ACCESS PORT DYE STUDY WAS ORDERED.

  Patient problems: Pain

  MAUDE report 17984280 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING INTRATHECAL UNKNOWN DRUG (CONCENTRATION AND DOSE UNKNOWN) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD THEIR PUMP IMPLANTED IN 2015 BUT THEN HAD IT REMOVED BECAUSE THEY THOUGHT "IT WAS KILLING ME." WHEN ASKED WHEN PUMP WAS REMOVED, THE PATIENT DID NOT KNOW AND WOULD HAVE TO CHECK IN THEIR MEDICAL RECORDS. IT WAS REPORTED AFTER THEY RECEIVED THE PUMP THEY GAINED OVER 100 POUNDS, BECAME PUFFY, RETAINED FLUIDS AND WERE CONFINED TO A WHEELCHAIR. IT WAS NOTED THE DOCTOR JUST KEPT UPPING THE MEDICATION. THE PATIENT MENTIONED ONCE THEY FOUND OUT THEY WERE GOING TO BE A GRANDMOTHER, THEY DECIDED THEY WANTED TO HAVE THE PUMP REMOVED BECAUSE "I COULD NO LONGER LIVE LIKE THIS". THE PATIENT'S DOCTOR REMOVED THE PUMP BUT DID NOT TAPER THE PATIENT OFF THE MEDICATION SO THE PATIENT WENT THROUGH"HORRID" WITHDRAWALS. IT WAS REPORTED TED AFTER THE PUMP WAS REMOVED THEY RECEIVED A LETTER FROM THEIR DOCTOR STATING THEY WERE RELEASED FROM THEIR CARE.

  Patient problems: Insufficient Information; Swelling/ Edema; Weight Changes

  MAUDE report 17881066 ↗
• MalfunctionSep 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT AND HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTED INFUSION PUMP SYSTEM FOR SPINAL PAIN. AT THE TIME OF THIS REPORT, THE PUMP WAS USED TO DELIVER FENTANYL 50MCG/ML. DOSE INFORMATION WAS NOT REPORTED. IT WAS REPORTED THAT THE PUMP WAS REPLACED ON 2023-09-24 FOR NORMAL BATTERY DEPLETION. UPON ENTERING THE CAPSULE SURROUNDING THE PUMP, THERE WAS A CHALKY WHITE FLUID ENCOUNTERED. THIS DID NOT APPEAR TO BE PURULENT AND THERE WAS NO ASSOCIATED ERYTHEMA OR BREAKDOWN. THE SURGEON SUSPECTED THAT THIS VERY WELL MAY HAVE BEEN ESSENTIALLY A LIQUEFICATION OF THE PRIOR POUCH THAT THE DEVICE HAD BEEN PLACE IN, AS IT WAS OVER SEVEN YEARS OLD. THIS WAS SENT FOR CULTURE, JUST TO BE CERTAIN, BUT ULTIMATELY THE CAPSULE WAS FULLY DISSECTED AND THE DEVICE WAS CAREFULLY ROTATED OUT. THE ATTACHMENT "FROM THE NAUSEA" WAS CAREFULLY REMOVED AND THE PUMP WAS PASSED TO THE BACK TABLE. THE FENTANYL FROM THE PRIOR PUMP WAS TRANSFERRED INTO THE NEW PUMP AFTER REMOVING THE SALINE FROM THE NEW PUMP. THIS WAS ACCOMPLISHED WITHOUT ISSUE. THE POCKET WAS COPIOUSLY IRRIGATED WITH BACITRACIN SALINE AS WELL AS BETADINE SOLUTION. AGAIN, T HERE DID APPEAR TO BE ESSENTIALLY BREAKDOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840833 ↗
• InjurySep 28, 2023Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT RECEIVING BACLOFEN 150 MCG/DAY 2000 MCG/ML VIA IMPLANTABLE PUMP. THE INDICATION USE WAS INTRACTABLE SPASTICITY. THE PATIENT REPORTED A CATHETER TEAR BACK IN 2020, BUT IT WAS FIXED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS PROVIDED BY THE HEALTHCARE PROVIDER (HCP). THE PATIENT WEIGHT WAS ASKED BUT UNKNOWN AT THIS TIME. THE PATIENT HAD SPASMS SYMPTOM. THE ISSUE WAS RESOLVED AFTER THE CATHETER REPLACEMENT.

  Patient problems: Muscular Rigidity

  MAUDE report 17836510 ↗
• InjuryAug 23, 2023Filling Problem; Adverse Event Without Identified Device or Use Problem; Filling Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER ON (B)(6) 2017 REGARDING A PATIENT RECEIVING MORPHINE (DOSE AND CONCENTRATION UNKNOWN) VIA AN IMPLANTED INFUSION PUMP. WHEN ASKED THE DOSE AND CONCENTRATION, IT WAS NOTED THAT IT WAS "UP AROUND 10" FOR THE FIRST SEROMA. THE INDICATION FOR USE WAS SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD A SEROMA WHERE FLUID COLLECTED AROUND THE PUMP. ABOUT 6-7 MONTHS AGO (RELATIVE TO (B)(6) 2017), THE HEALTHCARE PROVIDER (HCP) WENT TO FILL THE PATIENT'S PUMP AND THEY HAD A HARD TIME. IT REPORTEDLY TOOK 3 HCPS AND THEY THOUGHT THE PUMP WAS FLIPPED, BUT THEY DETERMINED IT WAS A SEROMA AND SOME FLUID LEAKED OUT. IT REPORTEDLY HAPPENED AGAIN "LIKE 2 MORE TIMES, MAYBE 3 TIMES" OVER THE LAST 6-7 MONTHS THAT THE PATIENT NOTICED. IT WAS NOTED THAT YOU COULD SEE THE SWELLING FROM THE SEROMA, AND THE SECOND TIME IT HAPPENED IT WAS NOTICEABLE AND THE PATIENT'S DAUGHTER POINTED IT OUT. THE PATIENT HAD NEVER EXPERIENCED SEROMAS WITH THEIR OLD 20ML PUMP, AND WONDERED IF IT WAS MAYBE CAUSED BY THE BIGGER PUMP. IT WAS NOTED THAT THE PATIENT CONTACTED BOTH THE DOCTOR AND SURGEON, BUT THEY BOTH TOLD THE PATIENT TO CALL THE OTHER ONE REGARDING THE INQUIRIES. THE PATIE

  Patient problems: Fluid Discharge; Foreign Body Reaction; Pain; Seroma; Swelling/ Edema

  MAUDE report 17604348 ↗

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-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-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-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-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.