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TYRX™ NMRM6133 (UDI 00763000101633)Recalls & reported problems

Medtronic, Inc. · ENVELOPE NMRM6133 NEURO ABSORB LRG US · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000101633), received between Apr 6, 2021 and Apr 6, 2021 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hypersensitivity/Allergic reaction1
  • Rash1

Recent adverse event reports

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

  • InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE AND HAD RASH STILL SURROUNDING THE SKIN AROUND THE PUMP IMPLANT INCISION SITE SEVERAL WEEKS AFTER SURGERY. THE PHYSICIAN WAS UNSURE IF THE PATIENT HAD AN ALLERGY TO THE IMPLANTED PRODUCTS OR IF IT WAS OTHER UNRELATED SENSITIVITIES RELATED TO THE SURGERY DRESSINGS. THE PATIENT WAS PUT ON STEROIDS AND THE RASH WAS GETTING BETTER AND WAS MUCH IMPROVED AT THE PATIENT¿S THREE WEEK POST-SURGERY CHECK. THE ANTIBACTERIAL ABSORBABLE ENVELOPE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: Hypersensitivity/Allergic reaction; Rash

    MAUDE report 11618858 ↗

Other Mesh, surgical, polymeric devices

All Mesh, surgical, polymeric devices →

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