SYNCHROMED ® II 8637-20 (UDI 00613994779229)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,766 adverse event reports that list this exact device (DI 00613994779229), received between Nov 24, 2015 and May 27, 2026 — classified as 2 deaths, 1,196 injuries, 568 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (466 reports).

40 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,766 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTED INFUSION PUMP FOR NON-MALIGNANT PAIN. THE PUMP WAS USED TO DELIVER UNKNOWN MORPHINE. IT WAS REPORTED THAT THE PATIENT NO LONGER HAD THE PAIN PUMP. THE PATIENT HAD "THE SMALLEST DEVICE THAT YOU WOULD PUT THE MEDICATION IN WAS TOO BIG" FOR THEIR BODY AND IT WAS HITTING THEIR RIB CAGE "SO BADLY". THE PATIENT COULD NOT CONFIRM WHAT YEAR THAT ISSUE OCCURRED. PATIENT SERVICES REVIEWED ELIGIBILITY REGARDING THE PUMP. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT REPORTED THAT HAD 3 MEDICATIONS AND ONE OF THEM WAS MORPHINE, BUT THEY COULD NOT REMEMBER THE OTHERS. THE PATIENT MENTIONED HAVING MEDICAL PROBLEMS.

  Patient problems: Insufficient Information

  MAUDE report 25311551 ↗
• InjuryMay 1, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WITH AN IMPLANTABLE PUMP CONTAINING UNKNOWN DRUG FOR NON-MALIGNANT PAIN AND LUMBAR RADICULOPATHY. IT WAS REPORTED THAT THE PATIENT INDICATED THEIR PUMP WAS REMOVED BECAUSE IT WAS NOT WORKING. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055773 ↗
• MalfunctionJan 6, 2026Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING MORPHINE DRUG VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THEY HAD A MORPHINE PUMP IN 2013, AND THEY USED TO GO TO GRAND RAPIDS PAIN INSTITUTE. THE PATIENT STATED THAT IN 2019, THE BATTERY WAS GOING TO BE DEAD, AND THEY HAD 'ISSUES WITH IT' AND THE PUMP WAS REPLACED. THE PATIENT STATED THEY FOUND A 'GRANULOMA ON SPINAL CORD' AND WAS GOING THROUGH WITHDRAWAL BECAUSE IT WAS STOPPING RIGHT ABOVE THE CATHETER. THE PATIENT STATED THAT THEY WERE PUT ON 'BUPRENORPHINE' AND PUT SALINE IN THE PUMP AND HAD TO FIND A NEW PAIN CLINIC.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23984656 ↗
• MalfunctionDec 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT PER PRE-OPERATIVE DIAGNOSIS IT STATED MALFUNCTIONING PUMP. THE PUMP WAS REMOVED ON (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744445 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED OCCURRED ON (B)(6) 2020 DUE TO INADEQUATE EFFICACY.

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

  MAUDE report 22378512 ↗
• MalfunctionMay 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND SPINAL CORD INJURY/SPINAL CORD DISEASE. IT WAS REPORTED THROUGH THE PATIENT'S WIFE IN THE BACKGROUND TELLING PATIENT THAT THE PATIENT'S PUMP MALFUNCTIONED ON (B)(6) 2018 AND IT WAS REPLACED (B)(6) 2018.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977842 ↗
• InjuryMar 21, 2025Adverse 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 VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT HER OTHER PAIN PUMPS WERE PUT IN WHILE THEY WERE GOING THROUGH WITHDRAWALS, AND THEY DID NOT WANT TO GO THROUGH THAT AGAIN. THE PATIENT STATED THAT THEY HAD 5 PUMPS, AND THEY ENDED UP IN THE HOSPITAL EVERY TIME DUE TO THEM NOT BEING REPLACED PRIOR TO END OF SERVICE (EOS).

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

  MAUDE report 21668674 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT HAD THEIR PAIN PUMP REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531652 ↗
• InjuryFeb 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING INTRATHECAL BACLOFEN AND TWO OTHER DRUGS VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT STATED THEY HAD NEVER HAD THE CATHETER REPLACED JUST THE PUMP WHEN IT 'MALFUNCTIONED'. THE PATIENT STATED THE FIRST TIME THE PUMP MALFUNCTIONED, THEY LOST THE ABILITY TO SWALLOW AND HAD A FEEDING TUBE.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 21481969 ↗
• InjuryNov 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 UNKNOWN MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENTS PUMP HAD BEEN REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20754173 ↗
• InjuryNov 1, 2024Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING DILAUDID (HYDROMORP HONE) (10 MCG/ML AT .481 MG/ DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT SHE WAS FEELING DECREASED EFFICACY OF HER THERAPY AND AN INCREASE IN PAIN FOR AN UNDETERMINED AMOUNT OF TIME. DURING HER CATHETER REVISION, THE PHYSICIAN NOTED THERE WERE SEVERAL COILED SEGMENTS OF CATHETER IN THE SPINAL POCKET. THERE WERE NO KNOWN ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. ACTION/INTERVENTION: THE PATIENT UNDERWENT A CATHETER AND PUMP REVISION ON (B)(6) 2024. THE PHYSICIAN REPLACED THE CATHETER (SPINAL AND PUMP ASPECT) AS WELL AS THE PUMP. THE PHYSICIAN ASPIRATED OFF THE CATHETER ACCESS PORT SUCCESSFULLY. OUTCOME: THE ISSUE WAS RESOLVED. THE HCP HAS NO FURTHER INFORMATION FOR MEDTRONIC. THE PATIENT WAS ALIVE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 20588176 ↗
• InjurySep 10, 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 PATIENTS FIRST PUMP AND CATHETER IMPLANTED IN 2012 HAD BEEN EXPLANTED ABOUT 1 MONTH AFTER IMPLANT DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20180202 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING INTRATHECAL MORPHINE AND FENTANYL (ALL UNKNOWN CONCENTRATION AND DOSE) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT SOME YEARS AGO THEIR PUMP WAS ONLY WORKING GREAT FOR SOME TIME AND THEN IT STOPPED WORKING AND HAD TO BE REMOVED. THE PATIENT INQUIRED ABOUT PUMP PHYSICIAN LISTINGS BECAUSE IT'S THE ONE THING THAT WORKED. THE ONE THEY HAD FAILED AND THE PATIENT STATED THAT SO INSTEAD OF FIGHTING WITH ALL THIS, THEN THE PATIENT BECAME DISTRACTED AND STATED THEY WERE A LITTLE VICIOUS LATELY, THE PAIN. THE PATIENT MENTIONED THEY DIDN'T WANT TO WORRY ABOUT ORAL PILLS AND THOUGHT THE PUMP WAS MUCH BETTER FOR THEM. THE PATIENT STATED THE PUMP MEDS WERE A MIX OF MORPHINE AND FENTANYL THEY BELIEVED, AND STATED THE HEALTH CARE PROVIDER'S LOCATION WAS IN DRURY, CT. THE AGENT CONFIRMED AFTER THE CALL THAT THE PATIENT'S PUMP WAS NOT INCLUDED IN ANY FIELD ACTION. THE AGENT SENT THE PHYSICIAN LISTING VIA EMAIL AND SENT A MAIL REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484188 ↗
• MalfunctionApr 4, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING UNKNOWN INTRATHECAL MEDICATION AT UNKNOWN CONCENTRATION/DOSES VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT MENTIONED THAT THEY HAD A PAIN PUMP ON THE OTHER SIDE OF THEIR LOWER BACK AND IT SEEMED TO BE GETTING CLOSER AND CLOSER TO THE IMPLANTABLE NEUROSTIMULATOR IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043208 ↗
• MalfunctionMar 14, 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 THE PUMP GOT BROKEN AND WAS NOT WORKING ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18907256 ↗
• MalfunctionJan 22, 2024Pumping Stopped; Application Program Problem; Pumping Stopped; Application Program Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING UNKNOWN INTRATHECAL MEDICATION AT UNKNOWN CO NCENTRATION/DOSE VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND POST SPINAL CORD INJURY. IT WAS REPORTED THAT THE HCP GOT AN ALERT FOR PUMP MOTOR STALL AND RECOVERY WHEN INTERROGATING THE PUMP. THE HCP CONFIRMED THAT TABLET SOFTWARE HAD BEEN UPDATED TO 2.0 VERSION BUT PATIENT STATED THEY HAD NOT HAD AN MAGNETIC RESONANCE IMAGING (MRI) SINCE PUMP IMPLANT. TECHNICAL SERVICES HAD THE HCP CHECK PUMP LOGS WHICH DID NOT SHOW ANY STALLS OR OTHER PUMP ISSUES. THE HCP CONFIRMED THAT PATIENT DID NOT REPORT ANY PROBLEMS WITH THERAPY AND THAT THEY HAD BEEN ROUTINELY FILLING THE PUMP. THE HCP STATED THAT PUMP WAS DUE TO BE REPLACED IN ABOUT A YEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552770 ↗
• MalfunctionJan 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECIEVED FROM THE PATIENT RECEIVING UNKNOWN INTRATHECAL MEDICATION AT UNKNOWN CONCENTRATION/DOSE VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN AND FAILED BACK SURGERY SYNDROME. THE PATIENT STATED 'THE OTHER ONE (PREVIOUS PUMP) FALTERED SO I'M VERY CONCERNED ABOUT THIS ONE.'

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479682 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT REPORTING THAT THE CAUSE OF THE CONTAMINATED PUMP WAS DUE TO A STACK OF 4X4 GAUZE BEING LEFT ON TOP OF THE PUMP AFTER THEY SEWED HIM UP. THE PUMP SITE CONTINUED TO GET FLUID AROUND THE PUMP. ABOUT A MONTH LATER THE PATIENT STATED THEY FINALLY FIGURED IT OUT AFTER HE GOT GANGRENE. THE GANGRENE WAS FROM PUMP TO SPINE. THE CONTAMINATED PUMP HAD INFECTION IN HIS SPINE, WHOLE BODY, SPINAL FLUID AND HIS BLOOD STREAM.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions; Pocket Erosion; Sepsis; Seroma; Unspecified Infection

  MAUDE report 17730848 ↗
• InjuryAug 3, 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 THE PATIENT RECEIVING DILAUDID (HYDROMORPHONE) 8.8 MG/DAY 30 MG/ML BUPIVACAINE 1.46 MG/ML/ 5 MG/ML FENTANYL 58.7 MCG/ML 200 MCG/ML VIA IMPLANTABLE PUMP. THE HEALTHCARE PROVIDER (HCP) REPORTED GRANULOMA AFTER MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED. THE GRANULOMA CAUSED LEG PAIN. TROUBLESHOOTING: ¿TITRATING DOSE DOWN AND WILL DECIDE¿. THE PATIENT WEIGHT AND MEDICAL HISTORY WERE ASKED BUT UNKNOWN AT THIS TIME. THE PATIENT STATUS WAS ALIVE AND NO INJURY. THE ISSUE WAS RESOLVED.

  Patient problems: Pain

  MAUDE report 17453715 ↗
• MalfunctionJul 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTED PUMP SYSTEM FOR NON-MALIGNANT PAIN, POST-LAMINECTOMY PAIN, AND FAILED BACK SURGERY SYNDROME. THE PUMP WAS PREVIOUSLY USED TO DELIVER HYDROMORPHONE. DOSE AND CONCENTRATION INFORMATION WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT'S PUMP AND CATHETER WERE GOING TO BE EXPLANTED AND THE PATIENT INQUIRED IF THE MANUFACTURER WANTED THEM BACK FOR ANALYSIS. PER THE PATIENT, THE CATHETER WAS "20-SOME-ODD YEARS OLD". WHEN ASKED ABOUT THE PLANNED EXPLANT, THE PATIENT STATED THAT "WHEN 'CARDICK'S LAW' WENT INTO EFFECT, THEY TOOK ME OFF THE THERAPY". IT WAS ALSO REPORTED THAT "THE PUMP - IF YOU WANT TO CALL IT MALFUNCTIONED AFTER A WHILE". THE PATIENT DID NOT KNOW IF IT WAS FROM THE BATTERY GETTING LOW. PER THE PATIENT, "IT USED TO MAKE THESE WEIRD SOUNDS". AT THE TIME OF THIS REPORT, IT WAS "SEVEN YEARS PAST WHEN THE BATTERY WENT DEAD". PER THE PATIENT, ONE DOCTOR WAS GOING TO DO THE EXPLANT, BUT EXPRESSED CONCERN ABOUT SURGERY COMPLICATIONS. THIS DOCTOR SAID THAT "NATURALLY THERE'S RISK WITH SURGERY - LIKE THE HOLE NOT HEALING OF WHERE THE CATHETER WAS". THE PATIENT ASKED THIS DOCTOR IF THEY WERE PLANNING ON REMOVING SCAR TIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17326431 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING UNKNOWN MEDICATION VIA IMPLANTED INFUSION PUMP. IT WAS REPORTED THE PATIENT HAD A PAIN PUMP IMPLANTED AND AN INTRATHECAL CATHETER THAT WAS ULTIMATELY REMOVED. IT CAUSED MORE ISSUES THAN HELPED. THE PATIENT HAS HAD PAIN IN THEIR BACK BECAUSE OF THE SURGERIES.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16724861 ↗
• InjuryJan 13, 2023Fluid/Blood Leak; Noise, Audible; Fluid/Blood Leak; Noise, Audible

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS RECEIVING DILAUDID (HYDROMORPHONE) (UNKNOWN CONCENTRATION OR DOSE) AND MARCAINE (UNKNOWN CONCENTRATION OR DOSE) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE LAST TIME THE PATIENT HEARD THEIR PUMP TICKING WAS "2-3 YEARS AGO," THEN "3 YEARS AGO," PATIENT'S SONCAME ON THE LINE AND STATED THEY FOUND OUT PATIENT'S PUMP WAS "LEAKING MEDICATION," AND WAS WHY A NEW PUMP WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16155219 ↗
• InjuryJan 9, 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 VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT GOT A PUMP INFECTION. THE PUMP WAS REPLACED BECAUSE OF THE INFECTION IN THE POCKET AND THE ISSUE MAY HAVE BEGAN IN 2013 BUT THE PATIENT SOUNDED UNSURE. THE PATIENT NOTED THEY LOST 1 PUMP BUT PATIENT SERVICES DID SEE THAT THERE WERE 2 PREVIOUS PUMP DEVICES AND ONE CURRENT PUMP DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 16126418 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS RECEIVING FENTANYL (2000 MCG AT 1215.73089 MCG/DAY), BUPIVACAINE 1(8.3 MG AT 11.12394 MG/DAY) AND MORPHINE (14.1 MG AT 8.5709 MG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT'S MIDBACK WAS TENDER TO LIGHT TOUCH. RECOMMENDED TRIGGER POINT INJECTIONS, EPIDURAL STEROID INJECTION AND UPDATED IMAGING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THAT THE PAIN HAD PAIN AT THE PUMP SITE. IT WAS NOTED THAT THE DEVICE PROTRUDES AT THE TOP OF THE SITE. TRIGGER SITE INJECTIONS WERE ORDERED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THAT THE PATIENT HAD NO PAIN RELIEF FROM STEROID INJECTION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THAT THE PREVIOUS TRIGGER POINT INJECTIONS WERE TEMPORARILY HELPFUL. THE PROVIDER WILL ORDER CLUNEAL NERVE BLOCK ON THE LEFT TODAY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THAT THE ISSUE WAS RES

  Patient problems: Discomfort; Insufficient Information; Pain; Sleep Dysfunction

  MAUDE report 16004500 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING DILAUDID (HYDROMORPHONE) (DID NOT ASK MG/ML AT DID NOT ASK MG/DAY) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE PATIENT'S PUMP AND CATHETER WERE REMOVED 3 WEEKS AFTER IT WAS IMPLANTED DUE TO MRSA INFECTION ON THE INCISION AREA. THE PATIENT STATED THAT THE HEALTHCARE PROVIDER TOUCHED THE INCISION WITH A STYLET AND THE PUMP MOVED AND STUFF CAME THROUGH EVERYWHERE.

  Patient problems: Bacterial Infection; Fluid Discharge; Post Operative Wound Infection

  MAUDE report 15673527 ↗

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-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

…and 25 more.