NA TM90T0 (UDI 00763000574598)Recalls & reported problems

Medtronic, Inc. · COMMUNICATOR TM90T0 PROX US EMANUAL · Class 3

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 00763000574598), received between Jun 16, 2026 and Jun 16, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Communication or Transmission Problem1
Display or Visual Feedback Problem1
Failure to Power Up1

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.

MalfunctionJun 16, 2026Display or Visual Feedback Problem; Failure to Power Up; Communication or Transmission Problem
INFORMATION WAS RECEIVED FROM A PATIENT RECEIVING INTRATHECAL DILAUDID (HYDROMORPHONE) VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS THE PATIENT REPORTED THEY WERE ABLE TO USE THE PERSONAL THERAPY MANAGER (PTM) ONCE YESTERDAY. THE PATIENT REPORTED THE COMMUNICATOR WOULD NOT TURN ON AFTER THEY DELIVERED A BOLUS YESTERDAY. THE PATIENT STATED THE SOLID GREEN LIGHT WAS ON WHEN PLUGGED INTO THE OUTLET BUT NO LIGHTS CAME ON THE WHEN UNPLUGGED FROM THE OUTLET. THE PATIENT STATED THE POWER BUTTON DID NOT TURN ON THE COMMUNICATOR AND THERE WAS NO BLUE-TOOTH LIGHT. THE PATIENT STATED THEY PRESSED THE POWER BUTTON AND THE BUTTON FELT LIKE IT WENT DOWN BUT THERE WAS NO LIGHT ON THE POWER BUTTON. PATIENT SERVICES ASKED THE PATIENT TO CLOSE ALL APPS AND CONNECT WITH THE HANDSET AND COMMUNICATOR AND THE PATIENT SAID THEY WERE GETTING NOT FOUND MESSAGE ON THE HANDSET SCREEN. THE AGENT ASSISTED THE PATIENT WITH RESETTING THE COMMUNICATOR AND THE COMMUNICATOR DID NOT POWER ON AFTER THE RESET, NO BLUE-TOOTH LIGHT. THE AGENT ASSISTED WITH TURNING BLUE-TOOTH ON/OFF AND LOCATION. THE ISSUE WAS NOT RESOLVED. A REQUEST WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE COMMUNICAT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25520922 ↗

Device details

UDI-DI	`00763000574598`
Brand	NA
Model	TM90T0
Company	Medtronic, Inc.
Product code	LKK · Pump, infusion, implanted, programmable
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 25, 2026

Device type (GMDN): Multiple active implantable device programmer

An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.

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All Pump, infusion, implanted, programmable devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.