SynchroMed® II 8637-40 (UDI 00643169530126)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,291 adverse event reports that list this exact device (DI 00643169530126), received between Aug 21, 2017 and Sep 9, 2026 — classified as 6 deaths, 1,594 injuries, 691 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (338 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 2,291 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Electromagnetic Interference

  Information was received from multiple sources (Healthcare Provider, Clinical Study) regarding a patient who was receiving Unknown Drug via an implantable pump for unknown indications for use. It was reported that the patient had a pump motor stall today. They are thinking it might be from her iPhone and due to a magnetic issue. Additional information received from the healthcare provider via a clinical study indicated that the motor stall resolved spontaneously. They believed that possibly the Apple iPhone cover had a magnetic reaction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689136 ↗
• MalfunctionJul 27, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037734 ↗
• InjuryJun 2, 2026Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN MORPHINE DRUG VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT WAS DUE FOR A PUMP REFILL ON (B)(6) 2024, ALARM DATE ON (B)(6) 2024. SHE WAS LIVING IN ANOTHER STATE AND SAID SHE WAS NOT COMING BACK AND WAS ADVISED BY US OF RISKS AND OPIOID WITHDRAWAL. WHEN THE PATIENT CAME IN ON (B)(6) 2024 THE PUMP WAS NOTED TO BE EMPTY. SHE WAS LETHARGIC, COLD AND CLAMMY, HAD LOST 12 LBS, HAD NAUSEA, VOMITING AND DIARRHEA WITH ELEVATED BLOOD PRESSURE AND PULSE. THE PUMP WAS FILLED WITH NORMAL SALINE AND SHE WAS SENT TO THE EMERGENCY ROOM FOR EVALUATION. IF SHE COULD FIND SOMEONE TO MANAGE HER PUMP WHERE SHE LIVED, THEY COULD CONSIDER RE-STARTING THERAPY.

  Patient problems: Alteration in Body Temperature; Diaphoresis; Diarrhea; High Blood Pressure/ Hypertension; Lethargy; Nausea; Vomiting; Weight Changes

  MAUDE report 25362275 ↗
• MalfunctionMar 19, 2026Migration or Expulsion of Device

  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 REPORTED THAT THE PUMP ¿ALWAYS FLIPPED WHEN THEY GOT IN A CERTAIN POSITION OR WHATEVER¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638750 ↗
• MalfunctionMar 19, 2026Migration or Expulsion of Device

  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 REPORTED THAT THE PUMP ¿ALWAYS FLIPPED WHEN THEY GOT IN A CERTAIN POSITION OR WHATEVER¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638574 ↗
• MalfunctionFeb 27, 2026Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING UNKNOWN BACLOFEN AND BUPIVACAINE VIA AN IMPLANTED PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED THE COMMUNICATOR REPLACEMENT DID NOT RESOLVE THEIR ISSUE. THE PATIENT REP CLARIFIED THE ISSUE WAS A TELEMETRY ISSUE. PATIENT WOULD SEE "CONNECTING" WITH NO OTHER VERBIAGE ON THE SCREEN AND HAD TO TAP CANCEL AND RELAUNCH THE APP AGAIN FOR THE PTM TO CONNECT TO THE PUMP. THE PATIENT ALSO WAS INTERMITTENTLY ENCOUNTERING ¿NO PUMP FOUND¿. THE PATIENT REP DISABLED AIRPLANE MODE AND CLEARED DATA OF THE HANDSET THEN ATTEMPTED SYNCING AGAIN. THE ISSUE RESOLVED. THE LAST REFILL WAS ON (B)(6) 2025. A REPLACEMENT HANDSET WAS REQUESTED FROM REPAIR. THE PATIENT REP CALLED BACK ON (B)(6) 2025 STATING THE EQUIPMENT WORKED 'FOR A FEW DAYS' AFTER CALLING LAST WEEK BUT YESTERDAY (B)(6) 2025 AND TODAY THE PATIENT HAD BEEN UNABLE TO BOLUS DESPITE THE EQUIPMENT BEING CHARGED AND THEIR DATA BEING CLEARED LAST WEEK. THE PATIENT HAD THE COMMUNICATOR REPLACED, BUT NEVER THE HANDSET AND THE HAN DSET MUST BE GETTING OLD BECAUSE THE PATIENT¿S PUMP BATTERY WAS DUE TO BE ROUTINELY REPLACED SOON. IT WAS NOTED THE PATIENT HAD NOT HAD ANY FA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474017 ↗
• MalfunctionFeb 26, 2026Application Program Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD ENCOUNTERED A MESSAGE ON THE PERSONAL THERAPY MANAGER (PTM) APPLICATION SIX TIMES WHERE IT SAYS "SYSTEM ERROR - THE SYSTEM HAS ENCOUNTERED AN UNEXPECTED ERROR, CONTACT TECHNICAL SUPPORT." THEY THOUGHT THERE WAS A CODE LISTED AS WELL BUT THEY DID NOT KNOW THE SPECIFIC CODE. PATIENT SERVICES WALKED THEM THROUGH STEPS TO REBOOT THE HANDSET AND COMMUNICATOR. THEY WERE THEN ABLE TO SUCCESSFULLY DELIVER A BOLUS. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER WHO REPORTED THAT THEY HAD SEEN A SYSTEM ERROR MESSAGE (CODE UNKNOWN) ABOUT 7 TIMES AND HAD NOT BEEN ABLE TO USE THEIR PTM. WHEN THEY TRIED TO CONNECT, IT SEEMED THAT THE LOCATION OF WHERE THEY HELD THE COMMUNICATOR HAD MOVED. IT WOULD GET STUCK AT 91% AND TAKE A LONG TIME TO CONNECT AFTERWARDS. PATIENT SERVICES CLARIFIED AND THE PATIENT CONFIRMED THAT THE PUMP ITSELF HAD NOT MOVED. PATIENT SERVICES ASSISTED THEM TO RESET THE DEVICE/SOFTWARE AND THE ISSUE WAS RESOLVED. ADDITIONAL INFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454847 ↗
• MalfunctionFeb 23, 2026Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT RECEIVING THERAPY VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THE COMMUNICATOR WAS TAKING TOO LONG AND DISPLAYING AN ERROR MESSAGE. IT WAS NOTED THAT THE COMMUNICATOR STOPS AT 91% AND THE PATIENT DID NOT FEEL LIKE SHE WAS GETTING HER BOLUSES. AN EMAIL WAS SENT TO REPAIR FOR A REPLACEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED THEIR REPLACEMENT DEVICE AND IT IS STILL DOING THE SAME THING. THE PATIENT DID NOT WANT TO TROUBLESHOOT AT THIS TIME AND STATED SHE WOULD CALL BACK AT A LATER TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414780 ↗
• InjuryFeb 13, 2026Infusion or Flow Problem; Material Integrity 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 THE PATIENT REPORTED NO ADVERSE SYMPTOMS, AND STATED THE DEVICE WAS WORKING WELL PRIOR TO SURGERY. IT WAS REPORTED THAT THEY WERE UNABLE TO ASPIRATE THE CATHETER. IT WAS REPORTED THAT UPON FURTHER EXAMINATION, THE CATHETER APPEARED TORN, AND THE HEALTHCARE PROVIDER (HCP) ELECTED TO REPLACE IT. THE EVENT WAS RESOLVED AT THE TIME OF REPORT AS THE HCP REPLACED CATHETER AND PUMP SUCCESSFULLY. THE CATHETER WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337022 ↗
• InjuryFeb 12, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT'S PUMP AND CATHETER WERE EXPLANTED ON (B)(6) 2025 DUE TO 'FAILURE'. THE PRODUCTS WERE RETURNED FOR EVALUATION AND A WARRANTY DETERMINATION REPORT WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327014 ↗
• MalfunctionJan 19, 2026Fluid/Blood Leak; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTED INFUSION PUMP FOR SPINAL PAIN INDICATIONS. IT WAS REPORTED THAT CATHETER ISSUES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109208 ↗
• MalfunctionJan 8, 2026Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM THE PATIENT REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN (UNKNOWN) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. THE PATIENT REP REPORTED THE PATIENT'S PUMP WAS BEEPING. THE PATIENT REP STATED THAT IT WAS BEEPING THREE TIMES EVERY TEN MINUTES. AGENT REVIEWED THE INFORMATION AND REDIRECTED THE PATIENT TO THEIR HEALTHCARE PROVIDER (HCP). ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTING THAT THE ALARM BEING HEARD WAS THE MOTOR STALL ALARM. THE CAUSE OF THE PUMP BEEPING WAS DUE TO A MAGNETIC RESONANCE IMAGING (MRI) STUDY. MOTOR STALL OCCURRED AND DID NOT RECEIVE REQUIRED SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007256 ↗
• MalfunctionJan 5, 2026Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTED INFUSION PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT'S PUMP HAD BEEN "DEAD FOR ALMOST 2 YEARS". THE PATIENT STATED THAT THEY HAD BEEN HAVING PROBLEMS WITH DIABETES AND OTHER SURGERIES. THE PATIENT MENTIONED THAT THEY OPERATED ON HIS SPINAL CORD ABOUT 5-6 MONTHS PRIOR TO THIS REPORT TO CLEAN OUT ALL THE SCAR TISSUE AND TRY TO RELIEVE PRESSURE FROM THE SPINAL CORD. THE PATIENT SAID THAT THEY HAD TO ADD 2 MORE SCREWS AND METAL FROM HIS ORIGINAL SURGERY. THE PATIENT STATED THAT THEY HAD TO PUT PLASTIC IN BETWEEN DISCS. THE PATIENT WOKE UP ONE MORNING AND WAS IN EXTREME PAIN. THE PATIENT WAS PREVIOUSLY ON MULTIPLE PAINKILLERS. THE PAINKILLERS WERE LARGELY INEFFECTIVE. THE PATIENT WAS DIAGNOSED WITH "SPIDER SYNDROME". THE PATIENT WAS UNABLE TO GET HELP FROM DIFFERENT HEALTHCARE PROVIDERS (HCP). THE PATIENT HAD TO HAVE 13 SURGERIES. THE PATIENT ALSO HAD A SPINAL CORD STIMULATOR (SCS), WHICH THEY WERE THANKFUL FOR. THE PATIENT STATED THAT TORADOL DID HELP TO RELIEF THE PAIN. THE PATIENT ALSO MENTIONED THAT THEIR PUMP STARTED ALARMING ABOUT A YEAR AND A HALF PRIOR TO THIS REPORT. THE PATIENT WAS

  Patient problems: Pain

  MAUDE report 23958703 ↗
• InjuryJan 2, 2026Infusion 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 THE CATHETER WOULD NOT ASPIRATE DURING BATTERY REPLACEMENT. IT WAS REPORTED THAT THE CATHETER WAS PARTIALLY EXPLANTED AND A NEW CATHETER PLACED AND THERAPY RESTARTED. THE CATHETER WAS LEFT IN THE SPINAL SEGMENT. UNABLE TO RETURN BECAUSE IT REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951184 ↗
• MalfunctionDec 29, 2025Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE HCP SENT OVER LOGS AND IT SHOWS THAT PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) ON (B)(6) 2025 -ON (B)(6) 2025 THERE WAS A MESSAGE THAT THE PUMP STOPPED AND IT HAD NOT SHOWN ANYTHING ELSE IN THE LOGS AFTER. THE COMPANY REP WAS NOT SURE IF PATIENT HAD THE PUMP CHECKED POST MRI. THE COMPANY REP STATED PATIENT HAD NOT HAD ANY WITHDRAWAL SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905675 ↗
• InjuryNov 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING UNKNOWN MORPHINE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT STATED THE PUMP MALFUNCTIONED IN (B)(6) OF THIS YEAR. THE PUMP AND CATHETER WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649904 ↗
• MalfunctionNov 4, 2025Failure to Disconnect; Material Integrity Problem; Failure to Disconnect; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING BACLOFEN (575 MCG/ML AT 126 MCG/DAY) VIA AN IMPLANTED PUMP. IT WAS REPORTED THAT DURING THE ROUTINE PUMP REPLACEMENT PROCEDURE THE SUTURELESS PUMP CONNECTOR COULD NOT BE REMOVED INTACT. THERE WERE NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PUMP CONNECTOR WAS REPLACED. 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 23462237 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) INDICATED THAT THE GRANULOMA IN 2020 WAS AT THE CATHETER TIP. THE INDICATION FOR THE PUMP REPLACEMENT WAS UNKNOWN. THE 2020 GRANULOMA WAS RESOLVED, AS "IT WAS REPLACED".

  Patient problems: Granuloma

  MAUDE report 23328076 ↗
• InjuryOct 15, 2025Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING MORPHINE ( 5 MG/ML AT 0.5 MG/DAY) VIA AN IMPLANTED INFUSION PUMP. THE INDICATION FOR USE WAS SPINAL PAIN. IT WAS REPORTED THE PATIENT WAS REFILLED, ON (B)(6) 2021, AND WAS TOLD THEY WOULD BE LOCKED OUT FOR 24 HOURS. THE PATIENT WAS STILL EXPERIENCING 8503 LOCKOUT ON (B)(6) 2021. THE PATIENT OBTAINED PRINTOUT WHICH INDICATED LOCKOUT WOULD LAST 106 HOURS AND 56 MINUTES. THE LOCKOUT WAS GOING TO EXPIRE AT 10:41PM ON (B)(6) 2021. THE PATIENT CONFIRMED UNDERSTANDING. THE PATIENT THEN MENTIONED AFTER THE REFILL THE FOLLOWING DAY, BECAUSE THE PATIENT COULDN'T BOLUS, THE PATIENT WENT INTO WITHDRAWAL AND FELT LIKE THEIR MUSCLES WERE PULLING AND FEET WERE PULLING. THE PATIENT NOTED THEY FELT BETTER TODAY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON (B)(6) 2025 REPORTING THAT WITH THE 1ST PUMP, THEY HAD AN MRI AND THE PUMP DID NOT TURN BACK ON FOR ABOUT 4 DAYS AND THEY WENT THROUGH SEVERE WITHDRAWALS AND HAD TO GO TO THE ER. THEY WERE ALSO DEHYDRATED AND VERY SICK AND ENDED UP IN THE HOSPITAL FOR 3-4 DAYS. THE PATIENT STATED THE PUMP DID NOT ALARM. THE PT STATED THE PUMP HAD NEVER ALARMED. THE PATIENT STATED TH

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

  MAUDE report 23300518 ↗
• MalfunctionSep 18, 2025Pumping Stopped; Pumping Stopped

  INFORMATION WAS RECEIVED FROM THE PATIENT RECEIVING INTRATHECAL MARCAINE (BUPIVACAINE) AND DILAUDID (HYDROMORPHONE) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT BELIEVED THE PUMP HAD QUIT WORKING SINCE TWO DAYS AGO. PATIENT STATED THEY THOUGHT THEY WERE GOING THROUGH WITHDRAWALS AND WERE IN PAIN. PATIENT STATED THEY HAVE HAD DIARRHEA FOR 2 DAYS AND WERE SO WEAK THEY COULD NOT HARDLY STAND. PATIENT STATED THEY WENT TO THE HOSPITAL YESTERDAY AND WAS SENT HOME. PATIENT STATED THEY WERE GETTING CODE 8532 ON THE PERSONAL THERAPY MANAGER (PTM). PATIENT STATED THEY WERE SCHEDULE FOR REPLACEMENT SURGERY AT THE HEALTHCARE PROVIDER OFFICE FOR (B)(6) 2025. PATIENT STATED THE SURGEON'S OFFICE TOLD HER THEY WERE NOT TAKING NEW PATIENTS. PATIENT ASKED WHAT TO DO. AGENT REVIEWED MEANING OF CODE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

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

  MAUDE report 23086253 ↗
• InjurySep 9, 2025Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEI VING MORPHINE 20MG/ML VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT WAS ON A HIGH DAILY DOSE AND THE PHYSICIAN WANTED TO CHECK THE PATIENT¿S PATENCY OF CATHETER. THERE WERE NO KNOWN ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. AFTER A DYE STUDY, THE CATHETER WAS UNSUCCESSFUL. A NEW CATHETER WAS IMPLANTED. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.THE HEALTHCARE PROVIDER (HCP) HAS NO FURTHER INFORMATION FOR MEDTRONIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012514 ↗
• MalfunctionAug 14, 2025Pumping Stopped; Pumping Stopped

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS RECEIVING DILAUDID (HYDROMORPHONE) VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT FOR 'ABOUT A WEEK NOW, LATER STATED 'MAYBE A WEEK AND A HALF AGO,' THE PATIENT'S PUMP HAD BEEN ALARMING. THE PATIENT REP THOUGHT IT WAS THEIR PERSONAL PHONE AT FIRST, BUT THEN IT WENT OFF AGAIN AND THEY DIDN'T EVEN HAVE THEIR PHONE WITH THEM, SO THEY WERE A LITTLE CONCERNED ABOUT IT. AGENT ASKED IF THE ALARM WAS A SINGLE TONE OR A DUAL TONE, AND CALLER STATED IT WAS PROBABLY SINGLE TONE, BUT THEN STATED 'IT'S LIKE A RING TONE ON YOUR PHONE.' IT WAS NOTED THE ALARM WENT OFF 'IT SEEMS LIKE SOMETIMES IT'S EVERY 20 MINUTES.' THE PATIENT'S LAST REFILL WAS ON (B)(6) AT 10:30AM. IT WAS ALSO REPORTED THE PATIENT WAS HAVING A LOT OF STOMACH PROBLEMS. THE CALLER MENTIONED THE PATIENT WAS SUSCEPTIBLE TO BLOOD CLOTS, AND THEY WERE WAITING ON INSURANCE APPROVAL TO HAVE A CT SCAN TO SEE IF THE BLOOD FLOW WAS FLOWING RIGHT, BECAUSE THE PATIENT WAS SUSCEPTIBLE TO BLOOD CLOTS. THE PATIENT WAS TOLD BY THE HEALTHCARE PROVIDER (HCP) THEY COULD NOT DO ANYTHING DUE TO WAITING ON INSURANCE AND TOLD THEM TO CALL MEDTRON

  Patient problems: Insufficient Information

  MAUDE report 22811363 ↗
• MalfunctionAug 14, 2025Device Alarm System; Insufficient Device Problem Information; Device Alarm System; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE PATIENT RECEIVING INTRATHECAL BUPIVACAINE AND MORPHINE (UNKNOWN) VIA AN IMPLANTABLE PUMP FOR NON-M ALIGNANT PAIN. THE PATIENT REPORTED THAT THEY HAD THE PUMP FILLED ON THE (B)(6) 2025 AND ON THERE WAS AN ALARM GOING OFF AND THEY DID NOT KNOW WHY. PATIENT STATED THE PUMP STARTED ALARMING WEDNESDAY OR THURSDAY. PATIENT CONFIRMED THE PUMP WAS DOING THE SINGLE TONE ALARM. AGENT REVIEWED NON-CRITICAL ALARM. PATIENT STATED THEY WERE SCHEDULED TO HAVE THE PUMP REPLACED BUT PATIENT ENDED UP IN THE HOSPITAL GETTING LEG AMPUTATED. PATIENT CONFIRMED THIS WAS NOT RELATED TO THE MEDTRONIC DEVICE/THERAPY. AGENT ASKED WHO MANAGING PHYSICIAN WAS, AND PATIENT STATED DOCTOR WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808846 ↗
• MalfunctionAug 7, 2025Failure to Disconnect; Infusion or Flow Problem; Failure to Disconnect; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT DURING A NORMAL END OF LIFE PUMP REPLACEMENT, THE HEALTHCARE PROVIDER (HCP) WAS NOT ABLE TO GET THE PUMP SEGMENT OFF OF THE PUMP SO THEY HAD TO USE AN 8780 TO REPLACE THE PUMP SEGMENT. THE COMPANY REPRESENTATIVE STATED 27.9 WAS THE NEW LENGTH BUT THEY WERE NOT SURE HOW MUCH OF THE PUMP SEGMENT WAS LEFT ATTACHED. THE HCP WAS ALSO UNABLE TO ASPIRATE THE CATHETER BUT THE HCP WAS NOT CONCERNED. THEY WERE AWARE THERE WOULD BE A GAP IN DRUG DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740042 ↗
• MalfunctionAug 4, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT, IN REGARDS TO IF THERE WAS A DEVICE, PATIENT/THERAPY OR PROCEDURAL ISSUE RELATED TO THE EMPTY PUMP, IT WAS "UNDETERMINED INSIGNIFICANTS, 'NEGLIGENCE'". THE PATIENT STATED THAT "IF WHOMEVER READS THE PUMP MUST HAVE A LEVEL OF KNOWLEDGE TO INFORM THE DOCTOR AND STAFF OF THE PUMP SHUT OFF AND ALARM, UP TO THE MINUTE MUST BE DOCUMENTED, IT IS IMPERATIVE¿.LIFE IN JEOPARDY". THE CAUSE OF THE EMPTY PUMP WAS NOT DETERMINED; "U.I., NOT SURE/PRODUCT LIABILITY" WAS REPORTED. THE PATIENT ALSO STATED THAT, IN REGARDS TO THE CAUSE OF THE EMPTY PUMP, "ONE COULD SPECULATE, HOWEVER SUPERVISORS AND DOCTORS ARE SOLELY RESPONSIBLE¿.THE TECHS NEED TO HAVE A DEGREE OF SOME NATURE. 'PRC' MUST EMPLOY ONLY QUALIFIED INDIVIDUALS. A TRAINED TECH COULD BE SUFFICIENT, IF A CLASS WAS TAKEN". IN REGARDS TO STEPS TAKEN TO RESOLVE THE EMPTY PUMP, "U.I." WAS REPORTED; THE PATIENT'S PUMP AND CATHETER REMAINED IN HIS BODY. THE EMPTY PUMP DID NOT RESOLVE; THE PUMP REMAINED INTACT ON THE PATIENT'S LEFT HIP UNDER THE SKIN. THE EVENT WOULD HOPEFULLY BE RESOLVED IN DECEMBER. THE PATIENT INQUIRED " HOW MANY PARTS IN A PUMP, THE LARGE ONE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22707270 ↗

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-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-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.