Intellis 97755Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000372095), received between Mar 10, 2026 and Mar 10, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Charging Problem” (1 report).

9 other recalls cover devices cleared under the same FDA submission (P840001); 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 10, 2026Failure to Interrogate; Overheating of Device; Charging Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PATIENT REPORTED ISSUES WITH CHARGING THEIR IMPLANT. PATIENT STATED THAT THE NEW CONTROLLER HAD NOT RESOLVED THE PROBLEM AND THAT THEY EXPERIENCED MORE ERRORS. PATIENT DESCRIBED THAT AT TIMES THE DEVICE DISPLAYED MESSAGES SUCH AS "UNABLE TO LOCATE DEVICE" AND "SYSTEM PROBLEM RM03." THEY EXPLAINED THAT THEY HAD TO REMOVE THE BATTERY, BLOW AIR ON THE PORT, AND WIPE THE PINS IN ORDER TO CONTINUE USE. PATIENT ALSO REPORTED THAT THE RECHARGER FEELS WARM WHILE CHARGING THE IMPLANT. AGENT HAD THE PATIENT TO RESET THE CONTROLLER. PATIENT DID NOT HAVE AC POWER CORD OR RECHARGER AVAILABLE FOR TROUBLESHOOTING. PATIENT BELIEVED ISSUE WAS WITH BATTERY PACK OR CONTROLLER. AGENT REVIEWED RM03 ERROR MESSAGE WITH PATIENT; PATIENT REQUESTED REPLACEMENT OF ALL DEVICES; AGENT ADVISED PATIENT THAT SERIAL NUMBERS AND TROUBLESHOOTING WERE REQUIRED TO VERIFY WHICH EQUIPMENT NEEDED REPLACEMENT. PATIENT ABRUPTLY DISCONNECTED THE CALL. PT CALLED BACK AND REITERATED DETAILS OF CASE. PT MENTIONED THEY HAD THE CONTROLLER REPLACED IN THE PAST AND "THAT DID NOT SEEM TO HELP." PT SAID THEY STILL GOT RM03. PT MENTIONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P840001. One submission often covers many models, so check the product and lot details in each record.

• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-1691-2024 · Mar 28, 2024 · Open, Classified
  Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
• Z-0780-2024 · Dec 19, 2023 · Open, Classified
  Model A710 Intellis Clinician Programmer Application, version 2.0.97
• Z-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• Z-1926-2016 · May 3, 2016 · Terminated
  Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or li
• Z-1147-2015 · Jan 9, 2015 · Terminated
  The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or m
• Z-1524-2014 · Feb 27, 2014 · Terminated
  Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced
• Z-0278-2014 · Sep 30, 2013 · Terminated
  Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
• Z-1536-06 · Aug 2, 2006 · Terminated
  Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis