NA TM90T0 (UDI 00763000004101)Recalls & reported problems
Medtronic, Inc. · COMMUNICATOR TM90T0 TDD PROX · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000004101), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Charging Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Charging Problem1
- Communication or Transmission Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Charging Problem; Communication or Transmission Problem
INFORMATION WAS RECEIVED FROM A PATIENT, RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE INFUSION DEVICE FOR SPINAL PAIN AND FAILED BACK SURGERY SYNDROME, REGARDING AN EXTERNAL DEVICE. IT WAS REPORTED THAT THE PATIENT HAS 'NOT BEEN ABLE TO SET ANYTHING UP', THE PATIENT STATED THE WI-FI BUTTON IS PERMANENTLY GREY AND THEY HAD TRIED PAIRING IT WITH THE DEVICE AND IT JUST KEEPS SAYING IT IS 'NOT FINDING IT'. THE TECHNICAL SERVICES SPECIALIST (TSS) ON THE CALL REVIEWED THAT THE PATIENT DOES NOT NEED TO USE THE WI-FI AT ALL AND THAT THE BLUETOOTH NEEDS TO BE ON. THE PATIENT THEN STATED THAT THE COMMUNICATOR WAS NOT CHARGED. THE PATIENT STATED THEY DID NOT HAVE A CHARGER FOR THE COMMUNICATOR. THE TSS SENT A REQUEST TO REPAIR TO REPLACE THE CHARGING CORD AS IT WAS LOST. THE PATIENT REPORTED THE ISSUE BEGAN BEFORE THEIR SURGERY IN APRIL. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REPORTING THAT THE CAUSE WAS DUE TO THE DEVICE PORT NO LONGER ACCEPTED ANY CHARGING CORD AND UNFORTUNATELY HAS THE SAME PROBLEM WITH THEIR BOLUS MACHINE. IT WAS MENTIONED THAT IT STILL TAKES FOREVER TO CHARGE IT SINCE THE CORD MOVES IN THE PORT. THE NEWER MAIN DEVICE WAS REPORTED AS WORKING GREAT BUT IT WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715995 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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