SYNCHROMED®II 8637-20 (UDI 00643169984219)Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00643169984219), received between Aug 10, 2018 and Aug 13, 2025 — classified as 49 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (13 reports).

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

39 other recalls cover devices cleared under the same FDA submission (P860004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 13, 2023Class IIOpen, Classified

   Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Application Program Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Application Program Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING SUFENTANIL AND FENTANYL VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD SOFTWARE VERSION 2.0.1700. THE REASON FOR CALL WAS THE PATIENT HAD A REFILL A COUPLE DAYS AGO AND THEY NOTICED THE REFILL DATE WAS RUNNING BACKWARDS ON THE HANDSET, THE DATE WAS SHOWING (B)(6) 2025. THE PATIENT ASKED HOW TO FIX THE ALARM DATE ON THE HANDSET. THE PATIENT REPORTED THE DEVICE TAKES A LONG TIME TO CONNECT TO DELIVER A BOLUS AND DEVICE GETS STUCK AT 90%, SINCE THEY HAD THE DEVICE. THE PATIENT DISLIKED THE NEW PERSONAL THERAPY MANAGER (PTM) AND LOVED THE OLD PTM. THE PATIENT HEARD A LOT OF PEOPLE HAVE PROBLEMS WITH THE NEW PTM. THE PATIENT'S NEXT REFILL WAS (B)(6) 2025. IT WAS NOTED THE PATIENT GET 10 BOLUSES A DAY. PATIENT SERVICE ASSISTED THE PATIENT WITH RESETTING THE COMMUNICATOR AND CLEARING THE DATA ON THE HANDSET. AGENT ASKED THE PATIENT TO CONNECT TO THE IMPLANT AND THE DEVICE CONNECTED VERY FAST TO THE IMPLANT, SHOWING A LOCKOUT SCREEN. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUES. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ALARM DATE

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

  MAUDE report 22795401 ↗
• InjuryJun 4, 2025Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIV ING MORPHINE 1.499MG/DAY 25MG/ML DRUG VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PHYSICIAN WAS NOT ABLE TO ASPIRATE CATHETER WHEN REPLACING THE PUMP. THIS HAPPENED BEFORE DISCONNECTING OLD PUMP AND THEN CONNECTING NEW PUMP AND STILL NOT ABLE TO ASPIRATE. THERE WERE NO KNOWN ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE CATHETER WAS REPLACED AND WAS ABLE TO ASPIRATE EASILY. THE OLD CATHETER WAS DISCARDED. THE ISSUE WAS RESOLVED. THE HEALTHCARE PROVIDER (HCP) HAS NO FURTHER INFORMATION FOR MEDTRONIC. NO SYMPTOM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139912 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL MORPHINE (5 MG/ML AT 0.36 MG/DAY) AND CLONIDINE (190 MCG/ML AT 13.88 MCG/DAY) VIA AN IMPLANTED PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED THAT THE PATIENT HAD ABRUPT WITHDRAWAL SYMPTOMS AND INCREASE IN PAIN. THE PATIENT HAD NO CHANGE DESPITE INCREASING PUMP RATE. THERE WERE NO REPORTED ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THIS ISSUE AND THERE WAS NO REPORTED DIAGNOSTICS/TROUBLESHOOTING PERFORMED. SURGERY FOR CATHETER REPLACEMENT WAS PERFORMED. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT AND THE PATIENT'S STATUS WAS "ALIVE- NO INJURY". THE PATIENT'S WEIGHT AND MEDICAL HISTORY WERE ASKED BUT UNKNOWN.

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

  MAUDE report 17915819 ↗
• MalfunctionJun 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REGARDING PATIENT RECEIVING BACLOFEN VIA AN IMPLANTABLE PUMP. THE INDICATION USE WAS FOR INTRACTABLE SPASTICITY. THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THEY REFILLED THEIR PUMP ON (B)(6) 2023 AND CHANGED THE DRUG CONCENTRATION FROM 4000 MCG/ML TO 2000 MCG/ML. IT WAS NOTED THAT SHE DID A BRIDGE BOLUS, AND THE PATIENT WAS DISCHARGED. THE HCP REALIZED THE BRIDGE BOLUS AND SIMPLE CONTINUOUS DOSE WAS PROGRAMMED INACCURATELY. SHE PROGRAMMED THE WRONG DOSE WHICH MADE THE BOLUS RUN IN OVER 11HRS AND 45MIN. BASED ON CALCULATIONS, THE BOLUS SHOULD HAVE RUN IN OVER 110 HRS. THE PATIENT WILL GO BACK TO THE CLINIC ON (B)(6) 2023. SHE WAS LOOKING AT THE REPORT WRONG AND NOTICED THE DURATION WAS 110 HOURS AND 48 MINUTES. IT WAS CONFIRMED THE ONLY PROGRAMMING THAT NEEDED CHANGING WAS THE SIMPLE CONTINUOUS DOSE FROM 840MCG/DAY TO 420MCG/DAY. NO SYMPTOM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050768 ↗
• MalfunctionMay 12, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). IT WAS REPORTED THAT A PUMP FLOW STUDY WAS INDICATED, BUT WAS NOT OBTAINED AS THE PATIENT MOVED OUT OF STATE. ON 2022-APR-20, 3.5 CCS WERE EXPECTED FROM THE RESERVOIR AND ONLY 0.5 WAS ASPIRATED. THE PATIENT RETURNED TWO WEEKS LATER ON 2022-MAY-04, AND 17.7 CCS WERE EXPECTED AND WERE EXACTLY ASPIRATED. ON 2022-JUL-19, THERE WAS AN EXPECTED AMOUNT OF 5 CCS WITH ONLY 1 CC RETURN. ON 2022-OCT-18, THERE WAS AN EXPECTED AMOUNT OF 4.8 BUT ONLY 1.5 CCS WERE ASPIRATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920155 ↗
• MalfunctionMay 12, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT RECEIVING UNKNOWN MEDICATION FOR NON-MALIGNANT PAIN. IT WAS REPORTED THE THAT AT THE LAST TWO REFILLS THE PUMP HAD OVERINFUSED. THEY HAD SET THE LOW RESERVOIR ALARM TO 4 ML AND ON (B)(6) 2023 THE EXPECTED VOLUME HAD BEEN 4.7 ML AND THEY WERE ONLY ABLE TO ASPIRATE 0.1 ML. IT WAS REPORTED THEY SET THE NEW LOW RESERVOIR ALARM TO 8 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920065 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT:THE CAUSE OF THE OVERDOSE SYMPTOM WAS BECAUSE THE PATIENT WAS OVER MEDICATED WHICH RESULTED IN HOSPITALIZATION AND SKILLED NURSING THEN WENT HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16562810 ↗
• MalfunctionJan 18, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN MORPHINE DRUG (20 MG AT 4.39905 MG/DAY), COMPOUNDED BACLOFEN (238 MCG AT 52.41463 MCG/DAY), AND BUPIVACAINE (16.8 MG AT 3.6952 MG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT A PHYSICAL EXAM SHOWED THAT THE CATHETER WAS STICKING OUT. THE CATHETER WAS FOUND TO BE DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194111 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORDERED TO HAVE AN MRI TO CHECK THE PUMP AND CATHETER AND RULE OUT A GRANULOMA. IT WAS CONFIRMED THAT THE CALLER WAS AN MRI TECH WITH NO FURTHER INFORMATION AND KNOWLEDGE OF PATIENT HISTORY.

  Patient problems: Granuloma

  MAUDE report 13509310 ↗
• InjuryJan 26, 2022Application Program Problem; Insufficient Device Problem Information; Data Problem; Application Program Problem; Insufficient Device Problem Information; Data Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING THERAPY VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL AND "THEY MUST HAVE DONE SOMETHING TO MY PUMP" BECAUSE "IT'S NOT DELIVERING MY MEDICINE". IT WAS STATED THAT THE NEXT REFILL DATE ON PUMP REPORT KEPT GOING FURTHER AND FURTHER OUT DESPITE THE PATIENT USING ALL THEIR BOLUSES. THE CALLER STATED THAT AFTER INITIATING A BOLUS THE SCREEN INDICATES IT STARTED BUT THEY ALSO GET "AN ERROR" SO THE PATIENT KNEW THEY WEREN'T ACTUALLY GETTING A BOLUS. IT WAS NOTED THAT THE COMMUNICATOR WAS "SEPARATING DOWN THE MIDDLE", THE CALLER WAS UNABLE TO CONFIRM THE WORDING OF THE ERROR OR RECREATE IT DURING THE CALL. IT WAS NOTED THAT THE PATIENT USES THEIR BOLUSES TO BE ABLE TO EAT AND THAT THEY WERE EXPERIENCING A LOT OF PAIN.

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

  MAUDE report 13358584 ↗
• InjuryJan 4, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING BACLOFEN (2000 MCG/ML AT 496.5 MCG/DAY) VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS CEREBRAL PALSY AND INTRACTABLE SPASTICITY. IT WAS REPORTED THAT ON (B)(6) 2021 THEY WERE EXPECTING 2.3 ML BUT GOT BACK 6.8 ML. THE PATIENT REPORTED NO SYMPTOM CHANGE BUT THEY HAD BEEN INCREASING THE DOSE OVER THE FALL AND THE DOSE WAS INCREASED ON THE 20TH TO 496.5 MCG/DAY. THE HCP WAS NOT AWARE OF ANY ACTIVITY CHANGES, BUT SHE STATED THAT SHE DIDN¿T ASK. THERE WERE NO ISSUES SEEN IN THE PUMP LOGS. THE NEXT PUMP REFILL WAS SCHEDULED FOR (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152212 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY REGARDING A PATIENT RECEIVING FENTANYL 400 MCG AT 140.72019 MCG/DAY AND CLONIDINE 400 MCG AT 140.72019 MCG/DAY VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THE PATIENT REPORTED INCREASED ABDOMINAL PAIN WHERE THEIR INTRATHECAL (IT) PUMP WAS PRESSING AGAINST HER ANTERIOR ILIAC CREST ON THE RIGHT SIDE CURRENTLY FOR THE PAST 2 TO 3 MONTHS. THE PUMP WAS REPROGRAMMED ON (B)(6) 2020. A POCKET SITE REVISION OCCURRED ON (B)(6) 2021. THE OUTCOME OF THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. THE CLINICAL DIAGNOSIS WAS INCREASED ABDOMINAL PAIN. THE ETIOLOGY OF THE EVENT INDICATED THE RELATIONSHIP OF THE EVENT TO THE DEVICE OR THERAPY WAS POSSIBLY RELATED AND INDICATED THE RELATIONSHIP OF THE EVENT TO THE IMPLANT PROCEDURE WAS POSSIBLY RELATED. THE INCISIONAL SITE/DEVICE TRACT WAS PUMP POCKET. THE EVENT DATE WAS (B)(6) 2020. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Abdominal Pain; Discomfort

  MAUDE report 12210560 ↗
• InjuryJul 12, 2021Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL LIORESAL 2000 MCG/ML AT 99 MCG/DAY VIA AN IMPLANTED PUMP. IT WAS REPORTED THE HCP WAS UNABLE TO ASPIRATE THE CATHETER. THE CATHETER WAS REPLACED WITH A NEW 8780 ON (B)(6) 2021 AND THE PREVIOUS CATHETER WAS DISCARDED. IT WAS FURTHER REPORTED THE PATIENT WAS EXPERIENCING WITHDRAWAL SYMPTOMS. THE PHYSICIAN WAS UNSUCCESSFUL AT ASPIRATING CEREBROSPINAL FLUID (CSF) FROM THE CATHETER. IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL, PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT AND THE PATIENT¿S STATUS WAS ¿ALIVE- NO INJURY.¿ THE PATIENT¿S WEIGHT AND MEDICAL HISTORY WERE ASKED AND WOULD NOT BE MADE AVAILABLE.

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

  MAUDE report 12153748 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY REGARDING A PATIENT RECEIVING FENTANYL AND CLONIDINE VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THE PATIENT'S PUMP WAS REPOSITIONED ON (B)(6) 2021. IT WAS INDICATED THE EVENT WAS POSSIBLY RELATED TO THE DEVICE OR THERAPY AND POSSIBLY RELATED TO THE IMPLANT PROCEDURE. FLUOROSCOPY WAS PERFORMED AND THE ISSUE WAS UNRESOLVED WITH NO FURTHER ACTION PLANNED. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER VIA A CLINICAL STUDY REPORTED THE PATIENT HAD BEEN EXITED FROM THE STUDY ON (B)(6) 2014 DUE TO WITHDRAWAL OF PATIENT BY PHYSICIAN.

  Patient problems: Insufficient Information

  MAUDE report 11685109 ↗
• MalfunctionMar 9, 2021Migration or Expulsion of Device; Obstruction of Flow; Migration or Expulsion of Device; Obstruction of Flow

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT RECEIVING BACLOFEN (2000 MCG/ML) VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THE PUMP HAD TURNED AND NOW THE CATHETER WAS PINCHED. THE ISSUE WAS FOUND IN (B)(6) 2020. IT WAS NOTED THAT THE PATIENT WAS WORKING WITH THEIR HEALTHCARE PROVIDER AND WOULD FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448282 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE ON (B)(6) 2021 REGARDING A PATIENT RECEIVING BACLOFEN (DOSE AND CONCENTRATION UNKNOWN) VIA AN IMPLANTED INFUSION PUMP. IT WAS REPORTED THAT THE PATIENT SHOWED UP FOR A REFILL APPOINTMENT AND IT WAS DISCOVERED THAT THERE WAS AN INFECTION AT THE PUMP SITE. THE PUMP SYSTEM WAS EXPLANTED. THE ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE UNKNOWN AND THE DIAGNOSTICS/TROUBLESHOOTING PERFORMED WERE UNKNOWN. THE ISSUE WAS CONSIDERED RESOLVED AT THE TIME OF REPORT AND IT WAS NOTED THAT IT 9-10 MONTHS PASSED BEFORE REIMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 11139100 ↗
• MalfunctionDec 21, 2020Improper Flow or Infusion; Improper Flow or Infusion

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING MORPHINE VIA AN IMPLANTED PUMP. THE PATIENT WAS CALLING TO REVIEW RECALL INFORMATION REGARDING THE PUMP. PER THE PATIENT, SHE FELT THAT THE PUMP WAS INTERMITTENTLY NOT WORKING. SHE STATED THAT SHE FOUND ONLINE THAT HER PUMP¿S SERIAL NUMBER WAS NOT INCLUDED IN A RECALL, BUT SHE WANTED TO KNOW SOME OF THE SYMPTOMS THAT ONE MIGHT EXPERIENCE. WHEN ASKED WHEN THE ISSUE BEGAN, THE PATIENT STATED, ¿IT HAS BEEN QUITE A WHILE AND IT IS INTERMITTENT¿. SHE STATED THAT SHE FELT THAT SHE WAS NOT GETTING THE MEDICATION ¿ALTHOUGH THE BIGGEST AMOUNT OF MEDICATION DIFFERENCE WAS LIKE, AH I CAN'T REMEMBER, POINT OH I DON'T REMEMBER IT ONLY HOLDS 20 SO I GUESS IT WAS LIKE 5". SHE STATED, "MY PAIN IS SO SEVERE IT FEELS LIKE ITS NOT WORKING". THE PATIENT THEN STATED, "MAYBE IT IS, AND THIS IS JUST MY PAIN". SHE STATED THE FEELING WAS INTERMITTENT AND IT GOT REALLY BAD AND THEN IT GOT BETTER ¿NOT BETTER, BUT YA KNOW BETTER". PER THE PATIENT, THE PUMP WAS NOT ALARMING. SHE STATED THAT HER PUMP ALARMED BEFORE WHEN SHE HAD AN MRI AND THE PUMP WOULD ALARM WHEN SHE GOT TO 2 ML OF MORPHINE LEFT IN THE PUMP. THE PATIENT ALSO STATED THAT SOM

  Patient problems: Pain

  MAUDE report 11045728 ↗
• InjuryNov 16, 2020Disconnection; Disconnection

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCAREPROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE WHO REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS REVISED BY CONNECTING THE 2 EXISTING PIECES OF THE CATHETER WITH A NEW COLLET.

  Patient problems: Seroma

  MAUDE report 10843674 ↗
• MalfunctionOct 26, 2020Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT RECEIVING ¿HEPARIN 800 UNITS/ML AT 800 UNITS/DAY¿ VIA AN IMPLANTABLE PUMP. THE HEALTHCARE PROVIDER REPORTED A RED ALERT, PUMP 400 HOURS PUMP OFF. THE HEALTHCARE PROVIDER CHECKED THE LOGS, AND IT WAS SEEN THE PUMP RECOVERED TODAY, AND THE MOTOR STALL HAPPENED ON (B)(6) 2020. IT WAS CONFIRMED THAT ON (B)(6) 2020, THE PATIENT HAD AN MRI, AND DID NOT HAVE THE PUMP CHECKED POST MRI. THE HEALTHCARE PROVIDER STATED THE PATIENT WAS ON A 3 WEEK REFILL CYCLE AND 800 FOR UNITS/DAY, AND NOTED NO SYMPTOMS, OR VOLUME DISCREPANCIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10733270 ↗
• InjuryOct 23, 2020Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING THE PATIENT¿S IMPLANTABLE DRUG INFUSION DEVICE. THE DRUG BEING DELIVERED WAS 25 MCG/ML PRIALT/ZICONOTIDE AT 1.5 MCG/DAY. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. A DYE STUDY WAS PERFORMED AND CATHETER WAS FOUND NOT TO BE PATENT. THERE WAS A REVISION AND REPLACEMENT ON (B)(6) 2020. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: Insufficient Information; Therapeutic Effects, Unexpected

  MAUDE report 10727142 ↗
• InjuryOct 9, 2020Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE CAUSE OF THE CATHETER CONNECTOR OCCLUSION WAS NOT DETERMINED.

  Patient problems: Decreased Respiratory Rate; Muscular Rigidity

  MAUDE report 10655497 ↗
• InjuryOct 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER REGARDING A PATIENT RECEIVING MORPHINE AT AN UNKNOWN CONCENTRATION AND DOSE VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2020 WITH BACK PAIN, RIGHT UPPER QUADRANT ABDOMINAL PAIN AND COMPLAINT OF THE PUMP NOT WORKING. THERE WERE NO RECENT PROGRAMMING CHANGES OR REPORTS OF SYMPTOMS POST REFILL. THE PATIENT WAS DIAGNOSED WITH DEHYDRATION AND METABOLIC ACIDOSIS. AN ESOPHAGOGASTRODUODENOSCOPY AND MRI OF THE PATIENT'S PELVIS AND SPINE WERE PERFORMED. THE CALLER REQUESTED A DEVICE MANUFACTURER CHECK THE STATUS OF THE PUMP.

  Patient problems: Abnormal Blood Gases; Complaint, Ill-Defined; Pain

  MAUDE report 10626638 ↗
• InjurySep 24, 2020Use of Device Problem; Insufficient Flow or Under Infusion; Positioning Problem; Use of Device Problem; Insufficient Flow or Under Infusion; Positioning Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT WHO REPORTED SEEING CODE 8286 (EMPTY PUMP) ON HIS PTM (PERSONAL THERAPY MANAGER) AND HE WANTED TO KNOW WHAT THE CODE MEANT. HE STATED THAT HE WAS VERY ANGRY AND HAD A BIG ARGUMENT WITH HIS HCP (HEALTHCARE PROFESSIONAL). THE MEANING OF THE CODE WAS REVIEWED WITH THE PATIENT AND IT WAS RECOMMENDED THAT HE CONSULT WITH HIS HCP FOR NEXT STEPS AFTER WHICH THE PATIENT DISCONNECTED THE CALL.

  Patient problems: Anxiety; Calcium Deposits/Calcification; Complaint, Ill-Defined; Distress; Renal Failure

  MAUDE report 10579332 ↗
• MalfunctionAug 11, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING MORPHINE VIA AN IMPLANTED PUMP. ON (B)(6) 2020 THE PATIENT¿S FRIEND/FAMILY MEMBER REPORTED THAT THE PATIENT¿S PUMP HAD BEEN ALARMING. SHE DESCRIBED THE CRITICAL ALARM AND SAID THAT IT STARTED EITHER YESTERDAY OR THE DAY BEFORE YESTERDAY. PER THE REPORTER, THE PATIENT HADN¿T HAD HIS PUMP REFILLED BECAUSE HE WAS RECOUPING FROM AN UNRELATED BACK SURGERY. HE HAD AN APPOINTMENT TO SEE HIS PUMP MANAGING PHYSICIAN ON MONDAY ((B)(6) 2020). THE REPORTER USED THE PATIENT¿S PTM (PERSONAL THERAPY MANAGER) TO CHECK THE ALARM BUT WAS UNABLE TO PROVIDE A CODE. THE NEXT REFILL DATE SHOWED AS (B)(6) 2020 AND THE LAST REFILL DATE WAS (B)(6) 2019. NO PATIENT SYMPTOMS/COMPLICATIONS WERE REPORTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10390590 ↗
• InjuryAug 10, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION WAS RECEIVED FROM AN HCP REPORTING THE PATIENT'S WEIGHT.

  Patient problems: Fatigue; Overdose

  MAUDE report 10385431 ↗

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-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-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-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.