SYNCHROMED®II 8637-40 (UDI 00643169984226)Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00643169984226), received between Sep 24, 2018 and Nov 24, 2025 — classified as 1 death, 69 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (20 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-0615-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA COMPANY REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE PUMP CONTAINING BACLOFEN (UNKNOWN) FOR INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. IT WAS REPORTED THAT THE PUMP WAS SCHEDULED TO BE REPLACED 2 DAYS AGO, BUT IT WAS DECIDED TO POSTPONE THE SURGERY DUE TO UNRELATED HEALTH ISSUES. THE PATIENT WAS ON ORAL BACLOFEN IN THE MEANTIME. CALLER STATED THAT PATIENT HAD BEEN IN THE INTENSIVE CARE UNIT (ICU) AND SHE WAS JUST INFORMED THAT THE PATIENT WAS IN ACTIVE WITHDRAWAL AND SEIZING. THE PLAN WAS TO GO AND DO THE PUMP REPLACEMENT TODAY. AGENT REVIEWED CONSIDERATIONS AROUND PUMP REPLACEMENT AND PRIME BOLUS SCENARIOS. REVIEWED OPTION FOR HCP TO PROGRAM A SINGLE BOLUS IF MEDICALLY APPROPRIATE. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA COMPANY REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT'S WITHDRAWAL AND SEIZING DID RESOLVE, AND THE PATIENT'S INTENSIVE CARE UNIT (ICU) STAY WAS RELATED TO WITHDRAWAL MANAGEMENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 23633107 ↗
• MalfunctionJun 25, 2025Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING 2000 MCG/ML BACLOFEN VIA AN IMPLANTED PUMP. IT WAS REPORTED THAT DURING THE ROUTINE PUMP REPLACEMENT PROCEDURE, THE PROVIDER WAS UNABLE TO PULL BACK CSF (CEREBROSPINAL FLUID), SO THE PUMP SEGMENT OF THE CATHETER WAS REPLACED. CSF WAS NOTED AFTER THE NEW PUMP SEGMENT WAS PLACED. IT WAS NOTED THAT THE PATIENT REPORTED NO ISSUE GETTING RELIEF. IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS NOTED TO BE RESOLVED, AND IT WAS INDICATED THAT THE HEALTHCARE PROVIDER HAD NO FURTHER INFORMATION TO PROVIDE REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325957 ↗
• MalfunctionJun 11, 2025Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) AND IT WAS REPORTED THE REP REQUESTED THAT THE PRODUCT BE RETURN FOR ANALYSIS. HOWEVER, THE PRODUCT WAS DISCARDED BY THE OR STAFF. THE PRODUCT WOULD NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182190 ↗
• InjuryJun 5, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) AND IT WAS REPORTED THAT THE EVENT WAS RESOLVED BY PLACING A NEW 8780 CATHETER. THE ENTIRE CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152842 ↗
• InjuryMay 27, 2025Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN (2000 MCG/ML AT 262.2 MCG/DAY) VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT AT THE PATIENT'S NORMAL EARLY REPLACEMENT INDICATOR PUMP REPLACEMENT, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT BEGAN SHOWING A RETURN OF SPASTICITY AND BACLOFEN WITHDRAWAL A COUPLE WEEKS AGO. THE CATHETER ASPIRATED WELL, BUT IT DID NOT DRIP FREELY AFTER IT WAS DISCONNECTED FROM PUMP. NO EXTERNAL FACTORS WERE INVOLVED. THE HEALTHCARE PROVIDER (HCP) DECIDED TO CUT THE CATHETER PROXIMAL TO THE ORIGINAL PUMP SEGMENT CONNECTOR, BUT THERE WAS STILL NO FREE FLOW OR DRIPS. THE HCP OPTED TO DO A FULL REPLACEMENT. THE ISSUE HAD BEEN RESOLVED.

  Patient problems: Muscular Rigidity

  MAUDE report 22090837 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WILL BE PROVIDED FROM A HEALTHCARE PROVIDER (HCP) STATED THAT THE CAUSE OF OBTUNDED WAS ATTRIBUTED TO POLY PHARMACEUTICAL ENCEPHALOPATHY WITH METABOLIC COMPONENTS. THE PATIENT WAS VENTILATOR AND CIRCULATORY SUPPORT. THEY UNCOMPROMISED THE DEVICE FUNCTIONALITY. THIS EVENT IS NO LONGER A REPORTABLE EVENT. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THE EVENT REPORTABLE. DUE TO GCH FUNCTIONALITY, THE COMPLAINT FLAG CANNOT BE FLIPPED TO 'NO' AS A REGULATORY REPORT EXISTS IN THIS PE.

  Patient problems: Cognitive Changes; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759825 ↗
• InjuryJan 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING LIORESAL 2000 MCG/ML AT 494MCG/DAY VIA AN IMPLANTABLE PUMP. THE PATIENT¿S MEDICAL HISTORY INCLUDED INTRACTABLE SPASTICITY. IT WAS REPORTED THAT DURING A ROUTINE PUMP REPLACEMENT, A LEAK WAS FOUND IN THE CATHETER JUST DISTAL TO THE COLLET. THERE WERE NO ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE OR DIAGNOSTICS OR TROUBLESHOOTING PERFORMED. A CATHETER REVISION WAS DONE. THE PUMP SEGMENT AND PORTION OF THE SPINE SEGMENT WAS REMOVED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT, AND IT WAS NOTED THAT THE HEALTHCARE PROVIDER WOULD NOT HAVE ANY FURTHER INFORMATION REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21089032 ↗
• InjurySep 27, 2024Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING UNKNOWN MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT HAD AN UNREGISTERED PUMP (SERIAL NUMBER (B)(6)) AND CATHETER (SERIAL NUMBER UNKNOWN) AND HAD A ROUTINE PUMP REPLACEMENT TO REPLACE THE PUMP. DURING THE REPLACEMENT PROCEDURE THE CATHETER HAD BEEN UNABLE TO ASPIRATE RESULTING IN THE CATHETER BEING REPLACED AS WELL. THE CATHETER HAD BEEN DISCARDED WITHOUT A WAY TO OBTAIN THE SERIAL NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322899 ↗
• MalfunctionSep 18, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING BUPIVACAINE, HYDROMORPHONE, AND FENTANYL VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT THEY WENT TO HAVE THEIR PUMP REFILLED YESTERDAY AND THE PUMP WAS ALARMING EVERY HOUR SAYING THAT THE MEDICATION WAS RUNNING LOW. THE PATIENT STATED THAT THE NURSE TOLD HER TO CALL IN TO FIND OUT WHY THE PUMP WOULD CONTINUE TO BEEP EVERY HOUR. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. 2024-09-17 PATL (CON): ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER (CON) STATED THAT LOW RESERVOIR ALARM OCCURRED AND EXPECTED 0.1 ML BUT ACTUAL WAS 9.2 ML. ACTION: THE PUMP WAS REFILLED AND PROGRAMMED. A SIDE PORT ACCESS WAS PERFORMED ON (B)(6) 2024 AND THERE WAS NO UNUSUAL INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250396 ↗
• MalfunctionAug 20, 2024Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN BACLOFEN (UNK MCG/ML AT UNK MCG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT HAD MAGNETIC RESONANCE IMAGING (MRI) TWO DAYS AGO AND CAME IN NOW TO GET PUMP INTERROGATED. HOWEVER, THERE WAS NO MOTOR STALL RECOVERY WAS SHOWING UP IN THE LOGS. THE TECHNICAL SERVICES (TSS) DISCUSSED REINTERROGATING AND RECHECKING FOR MOTOR STALL RECOVERY OR CHECKING FOR VOLUME DISCREPANCY IF THE HEALTHCARE PROVIDER (HCP) WAS CONCERNED. THE TSS DISCUSSED TELEMETRY MODE. THE HCP PLANNING TO INTERROGATE THE PUMP. THE HCP CONFIRMED THAT THE PATIENT WAS NOT SYMPTOMATIC BUT WAS ALSO ON A VERY LOW DOSE OF BACLOFEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006847 ↗
• InjuryAug 12, 2024Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING COMPOUNDED BACLOFEN (1750 MCG/ML AT 650 MCG/DAY) VIA AN IMPLANTED PUMP. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF INCREASED SPASTICITY IN THEIR LEGS IN THE RECENT ¿COUPLE MONTHS.¿ ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE DENIED. THE HCP DID A ROTOR DYE STUDY AND THERE WAS MINIMAL CSF (CEREBROSPINAL FLUID) ASPIRATED FROM CAP (CATHETER ACCESS PORT). THE PATIENT WAS GOING TO BE SCHEDULED FOR A CATHETER REPLACEMENT IN THE FUTURE SINCE THE CATHETER WAS 20 YEARS OLD AND THE PATIENT STATED THAT THE SPASTICITY WAS WORSE IN CERTAIN POSITIONS. THE SURGERY WAS NOT YET SCHEDULED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT, AND IT WAS INDICATED THAT THE HCP HAD NO FURTHER INFORMATION TO PROVIDE REGARDING THE EVENT AT THIS TIME.

  Patient problems: Muscular Rigidity

  MAUDE report 19960338 ↗
• MalfunctionJun 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN BACLOFEN (2000 MCG AT 610.33113 MCG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THERE WAS A CATHETER LEAK. (B)(6) 2024. E1: DOCUMENT CONTAINED NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537779 ↗
• MalfunctionMay 17, 2024Electromagnetic Interference; Pumping Stopped; Electromagnetic Interference; Pumping Stopped

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE CAUSE OF THE SHORT DURATION MOTOR STALL WAS NEVER DETERMINED. ALL REPORTED INFORMATION HAD BEEN RECEIVED AND CONFIRMED BY THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346204 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED PATIENT IDENTIFIERS AND WEIGHT. THE IMPLANT OF THE INFECTED PUMP HAD BEEN (B)(6) 2020 AND THE EXPLANT DATE WAS (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 18705067 ↗
• InjuryOct 24, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE AND CONFIRMED WITH THE PHYSICIAN THAT THE CAUSE OF THE PUMP SWITCHING ITSELF TO ¿SAFE MODE¿/MIN RATE AND RESET WAS NOT DETERMINED.

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

  MAUDE report 17996120 ↗
• MalfunctionOct 9, 2023Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WAS CANCER CHEMOTHERAPY. IT WAS REPORTED THAT THE CALLER, A HEALTHCARE PROVIDER (HCP), STATED THAT THEY SAW MOTOR STALL MESSAGE WHEN READING THE PUMP PRIOR TO A REFILL. WHEN ASKED IF PATIENT HAD MAGNETIC RESONANCE IMAGING (MRI) RECENTLY, THE HCP STATED THAT THEY DID AND CONFIRMED PUMP WAS LAST READ PRIOR TO MRI. THE MANUFACTURER'S TECHNICAL SERVICES SPECIALIST (TSS) REVIEWED TELEMETRY MODE. THE PATIENT HAD ALREADY LEFT SO THE HCP COULD NOT CHECK LOGS FOR STALL OR RECOVERY INFORMATION, BUT THE HCP STATED THAT THE EXPECTED VOLUME MATCHED DURING THE REFILL SO THEY THOUGHT PUMP WAS RUNNING. THE HCP STATED THEY WOULD LIKELY HAVE PATIENT COME BACK SO THEY COULD CHECK FOR A RECOVERY LOG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894845 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) INDICATED THAT THE PUMP SEGMENT OF THE CATHETER WAS ALSO REPLACED.

  Patient problems: Muscular Rigidity

  MAUDE report 17509520 ↗
• MalfunctionApr 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING HEPARIN (UNKNOWN DOSE AND CONCENTRATION) VIA AN IMPLANTABLE PUMP INDICATED FOR CANCER CHEMOTHERAPY. IT WAS REPORTED THAT THE HCP WANTED TO SHUT THE PUMP OFF AS THE PATIENT STARTED HAVING SYMPTOMS IN 2023. THE HCP STATED THAT THE PATIENT WAS HAVING ISSUES WITH THE CATHETER AS IT WAS A HEPATIC PUMP. THE HCP STATED THAT THE PATIENT'S CATHETER WAS CAUSING SOME BLEEDING AND LEAKING. THE HCP STATED THAT THE DOCTOR WOULD LIKE THE PUMP PERMANENTLY SHUT OFF AND TECHNICAL SERVICES PROVIDED CODE TO SHUT THE PUMP OFF. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16665824 ↗
• InjuryJan 31, 2023Insufficient Flow or Under Infusion; Obstruction of Flow; Infusion or Flow Problem; Material Integrity Problem; Insufficient Flow or Under Infusion; Obstruction of Flow; Infusion or Flow Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING COMPOUNDED BACLOFEN (1000 MCG/ML) VIA AN IMPLANTED PUMP. IT WAS REPORTED THAT AT THE PATIENT¿S LAST REFILL APPOINTMENT THE HCP WAS EXPECTING TO WITHDRAW 7 ML OF DRUG FROM THE RESERVOIR; HOWEVER, THEY WERE ABLE TO WITHDRAW APPROXIMATELY 14-15 ML. THE PATIENT TYPICALLY HAD SOME DISCREPANCY IN VOLUME (BETWEEN 2-3 ML) BUT THIS LAST ONE WAS MORE SUBSTANTIAL. A DYE STUDY WAS ATTEMPTED TODAY, BUT THEY WERE UNABLE TO ASPIRATE THE CATHETER, SO THE PROCEDURE WAS ABORTED. THEY EMPTIED THE RESERVOIR AGAIN TO COMPARE THE EXPECTED VERSUS THE ACTUAL VOLUME, AND THEY WERE EXPECTING 33.7 ML AND THE HCP WITHDREW 35 ML. THE HCP WANTED TO HAVE THE PATIENT GET ON THE SCHEDULE FOR AN OR (OPERATING ROOM) SO THEY COULD TAKE A CLOSER LOOK AT THE PUMP CONNECTION AND THE PROXIMAL CATHETER. THE HCP WAS UNSURE WHO WOULD BE DOING THE PROCEDURE, SOIT WAS PLANNED, BUT NOT YET SCHEDULED. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF WITHDRAWAL AND ¿FEELS NORMAL¿. IT WAS NOTED THAT THEY WOULD TENTATIVELY REPLACE THE PUMP AT THE PROCEDURE AS THE PATIENT ONLY HAD A YEAR OR TWO LEFT ON THE CURRENT PUMP. WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270451 ↗
• MalfunctionJan 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER RECEIVING HEPARIN (UNKNOWN DOSE AND CONCENTRATION) VIA IMPLANTED INFUSION PUMP INDICATED FOR CANCER CHEMOTHERAPY. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WANTED THE CODE TO SHUT OFF THE PUMP PERMANENTLY. THE CONSUMER NOTED THAT THE PUMP HAD NOT BEEN WORKING FOR THEM AS THEY ARE A HEPATIC ARTERY INFUSION (HAI) HEPARIN PATIENT. THE CONSUMER STATED THEY HAD NOT BEEN GETTING GOOD THERAPY AND WOULD LIKE THE DEVICE SHUT OFF. TECHNICAL SERVICES PROVIDED PASSWORD TO SHUT PUMP OFF PER REQUEST OF HCP. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REPORTING THAT THE PUMP FAILED IN FEWER THAN TWO YEARS OF OPERATION. THE CONSUMER NOTED THE PUMP FAILED WHERE THE PUMP MEETS THE CATHETER.

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

  MAUDE report 16122880 ↗
• MalfunctionDec 12, 2022Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN BACLOFEN (UNKNOWN CONCENTRATION OR DOSE) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT "WE REALIZED NOT LONG AGO THAT HIS PUMP WAS OFF AFTER HE HAD AN MRI IN SEPTEMBER. WE DIDN'T KNOW THAT THE PUMP WAS OFF FROM THEN UNTIL HE HAD A REFILL NOT LONG AGO." THE PATIENT WENT TO THEIR PHYSICIAN AND FOUND OUT THAT THE PUMP WAS NOT ON. IT WAS NOTED THAT THE PEOPLE AT THE MRI PLACE WERE SAYING THAT THEY WERE NOT ABLE TO REACH OUT TO ANYONE (MEDTRONIC). THE PATIENT REPRESENTATIVE CONFIRMED THAT THE PHYSICIAN FOUND OUT THAT THE PUMP DID NOT "TURN BACK ON" AFTER THE PATIENT'S MRI IN SEPTEMBER. THE PATIENT REPRESENTATIVE WAS UNABLE TO IDENTIFY THE DATE IN SEPTEMBER, BUT DID CONFIRM THE MRI WAS IN (B)(6) 2022. IT WAS NOTED THAT "HIS LEGS ARE BECOMING NUMB. FROM SEPTEMBER TO NOVEMBER, HE WAS WITHOUT BACLOFEN GOING THROUGH HIS BODY DUE TO THAT."

  Patient problems: Cramp(s) /Muscle Spasm(s); Numbness

  MAUDE report 15960325 ↗
• MalfunctionNov 4, 2022Device Alarm System; Migration or Expulsion of Device; Device Alarm System; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A CONSUMER WHO WAS RECEIVING DILAUDID AT AN UNKNOWN CONCENTRATION AND DOSE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PUMP MOVED OUT OF PLACE DUE TO THE PATIENT BEING STRESSED AND WEIGHT LOST. THE PATIENT MENTIONED THAT THE PUMP HURT AND MOVED AROUND. THE PATIENT STATED THAT THIS BEGAN A YEAR AGO AND THAT THEY WERE SUPPOSED TO HAVE IT REVISED LAST TUESDAY (B)(6) 2022 BUT THE HCP WASN¿T ABLE TO DO IT. THE PATIENT STATED THEY WOULD HAVE A REFILL ON (B)(6) 2022 AND THEY INQUIRED HOW LONG THEIR MEDICATION WOULD LAST. THE PATIENT ALSO MENTIONED THEY HEARD A BEEP LAST NIGHT BUT WAS NOT SURE IF THE BEEP WAS THE PUMP. THE PATIENT HAD NOT CONTINUED TO HEAR THE BEEPING. THE PATIENT DID NOT HAVE A PERSONAL THERAPY MANAGER. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROVIDER.

  Patient problems: Pain

  MAUDE report 15727485 ↗
• InjuryOct 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING BUPIVACAINE (UNKNOWN CONCENTRATION OR DOSE) AND FENTANYL (UNKNOWN CONCENTRATION OR DOSE) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD A LEAK IN THEIR CATHETER ONE YEAR AGO. THE PATIENT REPORTED THAT AFTER THE CATHETER WAS REPLACED, THEY HAD TO DECREASE THE MEDICATION. NO SYMPTOMS/PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15522423 ↗
• InjuryAug 19, 2022Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIV ING GABLOFEN (2000 MCG AT 1365NCG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT HAD BACLOFEN WITHDRAWAL SYMPTOMS. THEY WERE ADMITTED TO THE HOSPITAL AND THE PHYSICIAN ATTEMPTED ADYE STUDY, TO WHICH HE COULD NOT ASPIRATE THE CATHETER.  THE PATIENT WAS SCHEDULED FOR REPLACEMENT.  NO CEREBRAL SPINAL FLUID (CSF) DRIP FROM THE CATHETER WHILE THE PUMP POCKET WAS OPEN, NOR ANY CSF DRIP FROM SPINAL INCISION TO CHECK EFFICACY OF THE CATHETER.  THE PHYSICIAN COULD NOT ASPIRATE THE CATHETER DURING THE PREVIOUS DYE STUDY NOR DURING REPLACEMENT.  THE ENTIRE CATHETER AND PUMP WERE REPLACED.  POST PROCEDURE, THE EXPLANTED PUMP SHOULD HAVE HAD 9.8 CC AND THE NURSE RETRIEVED 21 CC FROM THE PUMP.  THE ISSUE WAS REPORTED TO BE RESOLVED.  THE PATIENT'S WEIGHT WAS ASKED BUT UNKNOWN.  THE PATIENT'S MEDICAL HISTORY WAS ASKED BUT WOULD NOT BE MADE AVAILABLE.  THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THIS REPORT.

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

  MAUDE report 15262898 ↗
• InjuryJul 8, 2022Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING GABLOFEN 2000MCG/ML AT 319 MCG/DAY VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT A DYE STUDY WAS NOT ABLE TO BE DONE DUE TO TROUBLE WITHDRAWING FROM THE CAP (CATHETER ACCESS PORT). IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE DIAGNOSTICS AND TROUBLESHOOTING PERFORMED WAS THE POCKET OPENED AND WITHDREW FROM CAP WITHOUT ISSUE. THEY REPLACED THE PUMP SEGMENT JUST IN CASE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT AND IT WAS NOTED THAT THE HEALTHCARE PROVIDER WOULD NOT HAVE ANY FURTHER INFORMATION REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14953082 ↗

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.