SYNCHROMED® II 8637-20 (UDI 00643169508149)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,588 adverse event reports that list this exact device (DI 00643169508149), received between Nov 10, 2016 and Sep 3, 2026 — classified as 1 death, 1,679 injuries, 908 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (331 reports).

2 FDA recall records name this device's identifier, 2 still open.

38 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-0614-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Aug 9, 2017Open, Classified

   Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.

   Z-0896-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,588 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Migration or Expulsion of Device; Insufficient Device Problem Information

  Patient problems: Pressure Sore/Ulcer; Tissue Breakdown

  MAUDE report 50594710 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50531776 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient (PT) who was receiving Unknown Drug via an implantable pump for non-malignant pain indications for use. It was reported that the patient's pump was removed in 2020, and the catheter was removed in (b)(6) 2021. Now, they had a shunt in their head that was put in to control brain swelling. PT had the catheter removed during a back procedure from their healthcare provider (HCP). When doing that, the catheter was connected to their spinal cord so bacteria got in it and they got bacterial spinal meningitis in (b)(6) 2021. When agent asked for drug info they said they tried different pain medicine but nothing helped with back pain; PT said the drugs no longer helped in the beginning of 2021 even after trying 5 or 6 of them. PT did not know explant dates because they ended up in the hospital in a coma.

  Patient problems: Coma; Meningitis; Swelling/ Edema

  MAUDE report 50306811 ↗
• MalfunctionJun 15, 2026Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THEIR PRIOR PUMP WAS EMPTY. [SEE PE 709106432 FOR CURRENT EMPTY PUMP].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25506686 ↗
• InjuryApr 20, 2026Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTED INFUSION PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE PATIENT'S PUMP BATTERY "WENT BAD", SO THEY HAD TO HAVE IT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933780 ↗
• InjuryApr 2, 2026Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING BACLOFEN VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY/POST SPINAL CORD INJURY USE. IT WAS REPORTED THAT THE PATIENT WAS REFILLED ON (B)(6) 2026 AND AT THAT TIME HE SAW AN ALERT THAT A MOTOR STALL HAD OCCURRED DUE TO A MAGNETIC RESONANCE IMAGING (MRI). THE HEALTHCARE PROVIDER (HCP) STATED THAT THEY REFILLED THE PUMP AND REPROGRAMMED IT AND NOW THE PATIENT WAS BACK IN THE CLINIC SAYING THAT THEY FELT LIKE THEY WERE GOING INTO WITHDRAWAL. THE HCP STATED THAT THE SYMPTOMS HAVE BEEN GOING ON FOR A WEEK OR SO. THE AGENT REVIEWED WITH THE HCP THAT THEY COULD TRY TO CHECK THE VOLUME IN THE MAIN RESERVOIR OR TRY TO ASPIRATE THROUGH THE CATHETER TO SEE IF THERE IS ANY KINK OR OCCLUSION. THE TECH SERVICE (TS) REVIEWED CONSIDERATION FOR THERAPEUTIC BOLUS IF MEDICALLY APPROPRIATE. THE HCP PROGRAMMED A SINGLE BOLUS AND WILL MONITOR PATIENT FOR A RESPONSE.

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

  MAUDE report 24767508 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM THE PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP. THE PATIENT REPORTED THAT THEIR WHOLE SYSTEM WAS REMOVED BY THE HEALTHCARE PROVIDER (HCP) AND STATED THAT THE REASON FOR THE REMOVAL WAS THAT IT ALMOST KILLED HER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24011168 ↗
• InjuryJul 30, 2025Unintended Electrical Shock; Unintended Electrical Shock

  INFORMATION WAS RECEIVED FROM THE PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS RE PORTED THAT PER CALL FROM PATIENT, SHE GOT ELECTROCUTED BY HER MEDTRONIC NEURO PUMP FOR 3 DAYS AFTER IT GOT IMPLANTED AND THAT WAS WHY ENTIRE SYSTEM OF HER NEURO PUMP GOT EXPLANTED.

  Patient problems: Electric Shock

  MAUDE report 22664241 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM THE PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP. THE PATIENT REPORTED THAT THAT HER NEURO PUMP AND [CATHETER] WAS EXPLANTED DUE TO A LEAK IN HER SPINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 22613350 ↗
• InjuryJul 25, 2025Material Integrity Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA THE COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PUMP HAD REACHED THE END OF ITS SERVICE LIFE. THE FAMILY AND CARE PROVIDERS FELT THAT HIS TONE WAS STABLE AND THAT THE DEVICE CONTINUED TO PROVIDE BENEFIT. IT WAS REPORTED THAT PER OPERATIVE RECEIVED, PROCEDURE SPECIFIED THAT THE CATHETER APPEARED WITHOUT LEAK BUT NOTED AN AREA OF MINOR EROSION IN THE OUTER PLASTIC COATING OF THE CATHETER, EITHER FROM DISSECTION OF FRICTION WITH THE PUMP. THE DEVICES WERE BOTH REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612542 ↗
• MalfunctionJul 24, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE PUMP INFUSING UNKNOWN MORPHINE AND UNKNOWN BACLOFEN AND AN UNKNOWN DRUG FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT MENTIONED THEIR PUMP WENT EMPTY A LONG TIME AGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587227 ↗
• InjuryJun 4, 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 BUPIVACAINE, CLONIDINE, UNKNOWN MORPHINE DRUG, AND UNKNOWN BACLOFEN VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN INDICATIONS FOR USE. IT WAS REPORTED THAT HER PREVIOUS PUMP WAS REPLACED DUE TO INFECTION. THE PATIENT STATED THAT SOMEONE LEFT THE CATHETER IN. THE PATIENT SAW THE PHYSICIAN FOR SEVERAL YEARS AND HAD TO GET A NEW PUMP AS THE BATTERY WAS RUNNING OUT AND PUT NEW ONE IN AND THAT BECAME INFECTED. THE PHYSICIAN REMOVED THE PUMP AND WAS LEFT WITHOUT ANY PAIN MANAGEMENT. THE PATIENT ENDED UP AT (B)(6). THE PHYSICIAN STATED HE WOULD DO A FOLLOW UP FOR HER ISSUE. THE PHYSICIAN REMOVED THE PUMP AND DEALT WITH THE CATHETER AND PUT NEW ONE IN. THE PATIENT CURRENTLY HAS A SYNCH III PUMP IMPLANTED. *SEE (B)(4) FOR INFECTION**

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146318 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT RECEIVING UNKNOWN MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PATIENT HAD A SYSTEM EXPLANT ON (B)(6) 2016 DUE TO INFECTION. POST SURGERY THE INCISION WOULD NOT HEAL AND THEY HAD A SECOND SURGERY TO CLEAN THE WOUND SITE AND WERE PLACED OF KEFLEX.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 22112374 ↗
• InjuryMay 20, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING DILAUDID (HYDROMORPHONE) (3.5 MG/ML AT UNK MG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) STATED THAT THE PATIENT HAD A FLIPPED PUMP AND THEY WERE DOING A REVISION TODAY TO CORRECT THIS. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) STATED THAT THE PATIENT HAD A FLIPPED PUMP AND THEY WERE DOING A REVISION TODAY TO CORRECT THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057616 ↗
• MalfunctionMay 9, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT'S PUMP HAD NOT BEEN FILLED IN THREE YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996444 ↗
• MalfunctionApr 2, 2025Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT RECEIVING BACLOFEN VIA IMPLANTABLE PUMP. THE INDICATION USE WAS I NTRACTABLE SPASTICITY. IT WAS REPORTED THAT THEY REFILLED HER PUMP TWO WEEKS AGO AND INCREASED THE RATE. IT WAS SENT TO DELIVER A BOLUS DAILY, BUT NOW THE PUMP IS RAPIDLY ALARMING. THE PATIENT STATED THAT THEY DID INTENSE PHYSICAL THERAPY TODAY WHERE THEY HAD HER STRAPPED UP INTO ALL SORTS OF CONTRAPTIONS AND IT WAS HURTING A LITTLE BIT, BUT THEY PUT A GEL PACK ON IT, SO IT WENT RUBBED BUT THEY THINK THEY WERE PROBABLY RUBBED. THE PATIENT ALSO MENTIONED THAT THEY HAVE A VERY BAD URINARY TRACT INFECTION (UTI) SO THEY THOUGHT THAT WAS WHAT IT WAS, BUT THEY NEED TO FIGURE OUT WHERE TO GET IT CHECKED BECAUSE THEY HAD GONE THROUGH WITHDRAWALS TWICE IN HER LIFE IN 20 YEARS AND IT SCARES HER TO DEATH BECAUSE HER MENTAL STATE IS SEVERELY ALTERED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) TO FURTHER ADDRESS THE ISSUE. THE PATIENT STATED THAT THE HCP WAS CLOSED BUT THEY SPOKE TO THE NURSE WHO DIRECTED THE PATIENT TO THE EMERGENCY ROOM (ER). THE PATIENT MENTIONED THAT THEY HAVE A TRAUMATIC B

  Patient problems: Cognitive Changes

  MAUDE report 21753630 ↗
• InjuryMar 13, 2025Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Device Problem Information; Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING UNKNOWN INTRATHECAL MEDICATION AT UNKNOWN CONCENTRATION/DOSE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. PATIENT SAID THEY HAD A PUMP REPLACED ABOUT 2 YEARS AGO BECAUSE IT WAS DEFECTIVE AND IT SHUT OFF ON HIM. PATIENT SAID THE LAST TIME THE PUMP WENT OUT ON HIM THEY HAD TO GO TO THE EMERGENCY ROOM (ER).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pocket Erosion

  MAUDE report 21596217 ↗
• InjuryFeb 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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 THEIR FIRST PUMP WAS REPLACED BECAUSE ¿IT WAS COMPLETELY TRASH AND DIDN'T WORK.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21408866 ↗
• MalfunctionJan 28, 2025Insufficient Flow or Under Infusion; Battery Problem; Insufficient Flow or Under Infusion; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON (B)(6) 2025 WHO REPORTED THAT THEY NEEDED TO GET THEIR PUMP SETTINGS CHANGED AND THE PUMP WAS BEEPING BECAUSE IT WAS EMPTY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025 FROM THE PATIENT WHO REPORTED THE PUMP HAS BEEN ALARMING SINCE MONTHS AGO. THE PATIENT STATED THEY HAD TO STOP USING THE PUMP BECAUSE HE COULD NOT AFFORD TO GET THE PUMP REFILLED ANYMORE. THE PATIENT WAS REQUESTING HAVE SOMEONE TO COME TO TURN OFF THE PUMP ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253877 ↗
• MalfunctionNov 22, 2024Migration or Expulsion of Device; Insufficient Device Problem Information; Migration or Expulsion of Device; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT PREVIOUSLY RECEIVING INTRATHECAL HYDROMORPHONE AND BUPIVACAINE (CONCENTRATIONS AND DOSES UNKNOWN) VIA AN IMPLANTED PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THE PATIENT AND THE HEALTHCARE PROVIDER (HCP) MADE THE DECISION TO ABANDON THERAPY AS THE HCP NO LONGER IMPLANTS PUMPS. IT WAS NOTED LAST (B)(6), THE HCP REMOVED MEDIATION FROM PUMP AND PUT IN SALINE. THE PATIENT WENT THROUGH WITHDRAWAL. THE PATIENT WAS TOLD THE PUMP WOULD "SIGNAL IN AUGUST" AND PATIENT ASKED WHAT THAT MEANT. PSS REVIEWED ERI AND EOS/ALARMS AND CONSIDERATIONS. THE PATIENT PLANNED TO LEAVE THE PUMP IMPLANTED AND ASKED IF THAT WOULD HARM THE PATIENT. THE PATIENT INQUIRED HOW TO SILENCE THE ALARM. THE PATIENT ASKED IF THEY CHOOSE TO LEAVE THE ALARM GOING WOULD THAT HARM THE PATIENT. IT WAS NOTED THE PUMP WAS IMPLANTED FOR PERIPHERAL NEUROPATHY AND THE HCP WAS GOING TO TRY AND PURSUE PILLS, BUT GABAPENTIN DIDN'T WORK. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER ON(B)(6)2022 AND THE PATIENT WAS TOLD THE ALARM WOULD START TO SOUND ON (B)(6)2022. THE PATIENT ASKED HOW TO SILENCE THE ALARM SO IT DID NOT BOTHER THE PATIENT¿S ILL HUSBAND. ADDITIONAL

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

  MAUDE report 20760074 ↗
• MalfunctionNov 20, 2024Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING MORPHINE VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THEY WERE DOING A PUMP REPLACEMENT FOR NORMAL ERI (ELECTIVE REPLACEMENT INDICATOR), AND THEY COULD NOT ASPIRATE FROM THE CAP (CATHETER ACCESS PORT). THE CAUSE FOR THE INABILITY TO ASPIRATE FROM THE CAP WAS UNKNOWN. THE ACTIONS AND INTERVENTIONS TAKEN TO RESOLVE THE ISSUE WAS A NEW PUMP SEGMENT WAS ADDED TO THE OLD CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20731479 ↗
• MalfunctionOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT RECEIVING UNKNOWN MEDICATION VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PUMP HAD BEEN TURNED OFF BECAUSE IT HAD NOT BEEN FUNCTIONING AND THERE WAS "SOME OTHER ISSUES WITH IT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427345 ↗
• MalfunctionOct 7, 2024Material Integrity Problem; Material Integrity Problem

  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 PUMP BATTERY WAS BEING EXCHANGED DUE TO NORMAL BATTERY DEPLETION WHEN THE DOCTOR NOTICED A BOVIE BURN ON THE CATHETER SO IT WAS REVISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384465 ↗
• MalfunctionSep 27, 2024Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) REPORTING THAT THE CAUSE OF THE INABILITY TO ASPIRATE THE CATHETER WAS NOT DETERMINED. A BACK TABLE PRIME WAS PERFORMED PER THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322223 ↗
• MalfunctionSep 20, 2024Device Alarm System; Device Alarm System

  ON 2024-09-17 (B)(4) (HCP) INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL HYDROMORPHONE (UNKNOWN CONCENTRATION AND DOSE) VIA AN IMPLANTED PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT STATED THEY WERE HEARING A SINGLE TONE ALARM EVERY THIRTY MINUTES AND WHEN INTERROGATING THE PUMP THERE WERE NO ALERTS. THE AGENT REVIEWED INFORMATION AROUND CONCURRENT ALARMS WITH RECENT SOFTWARE UPDATE. THE CALLER DID NOT THINK THAT THE PATIENT HAD A LOW RESERVOIR ALARM AT LAST PUMP REFILL BUT DID NOT CONFIRM THAT "ACTIVE ALARM" BUTTON WAS PRESENT ON THE PROGRAMMER. THE AGENT REVIEWED THE STEPS TO SILENCE THE CURRENT ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271866 ↗

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-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
• Z-1214-2010 · Mar 23, 2009 · Terminated
  Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.

…and 23 more.