TYRX™ NMRM6122 (UDI 00763000307899)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000307899), received between Jan 6, 2021 and Nov 15, 2024 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

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

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THIRTEEN WEEKS POST IMPLANT OF AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT EXPERIENCED A POCKET INFECTION. IT WAS NOTED THAT THE PATIENT HAD MULTIPLE ALLERGIES AND MAY HAVE REACTED TO THE IMPLANTED ENVELOPE. ANTIBIOTICS WERE ADMINISTERED AND SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 20694694 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL (HCP) THAT A FEW DAYS POST-IMPLANT OF A URINARY STIM IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT DEVELOPED AN ALLERGIC REACTION WHICH PROGRESSIVELY WORSENED. THE PATIENT HAD EXPERIENCED A SYSTEMIC RASH, EXTREME ITCHING, AND BLISTERING OVER THE IMPLANT SITE. IT WAS FURTHER REPORTED BY THE PATIENT THAT THEY HAD BROKEN OUT WITH BLISTERS ALL OVER THEIR HANDS AND FEET. THE SYSTEM WAS LATER EXPLANTED FOR POTENTIAL INFECTION OR ALLERGIC REACTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Blister; Itching Sensation; Rash; Unspecified Infection

  MAUDE report 19938692 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE WEEKS AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN AND TENDERNESS AT THE DEVICE POCKET WHERE AN ABSORBABLE ANTIBACTERIAL ENVELOPE WAS USED. THE PATIENT WAS GIVEN PAIN MEDICATION. THE POCKET WAS REVISED AND THE ENVELOPE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 19588352 ↗
• MalfunctionApr 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE CAUSE OF THE CHANGE IN IMPEDANCE WAS UNABLE TO BE DETERMINED, AND THE ANTIBACTERIAL ABSORBABLE ENVELOPE WAS NEVER IMPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082531 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT CULTURES FROM THE SITE WERE FOUND TO BE INFECTED WITH CUTIBACTERIUM ACNES.

  Patient problems: Bacterial Infection; Fluid Discharge; Wound Dehiscence

  MAUDE report 19041144 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ABOUT THREE MONTHS AFTER THE IMPLANT OF A NEUROSTIMULATION DEVICE, THAT WAS IMPLANTED WITH AN ANTIBACTERIAL ABS ORBABLE ENVELOPE, THE PATIENT DEVELOPED A POCKET INFECTION WITH PURULENT DISCHARGE AND PAIN. THE SYSTEM WAS EXPLANTED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 18092256 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLERGIC REACTION TO THE ABSORBABLE ANTIBACTERIAL ENVELOPE TWO WEEKS AFTER IMPLANT. THE PATIENT HAD A RASH IN THE STOMACH AREA OF WHERE THE ABSORBABLE ANTIBACTERIAL ENVELOPE WAS IMPLANTED. THE PATIENT WAS TREATED WITH STEROIDS AND THE RASH WENT AWAY. THE ABSORBABLE ANTIBACTERIAL ENVELOPE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Rash

  MAUDE report 17164863 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS AFTER THE PATIENT WAS IMPLANTED WITH A DEVICE, THE PATIENT DEVELOPED A HEMATOMA AT THE IMPLANT SITE. THE SITE WAS EVACUATED AND AN ABSORBABLE ANTIBACTERIAL ENVELOPE WAS USED FOR THE DEVICE RE-IMPLANT. TWO MONTHS LATER, THE PATIENT DEVELOPED AN INFECTION. THE ABSORBABLE ENVELOPE WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15705589 ↗
• MalfunctionSep 26, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT FIVE WEEKS POST IMPLANT OF A URINARY STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) WITH AN ABSORBABLE ENVELOPE, THE PATIENT HAD URINARY INCONTINENCE AND IT WAS FOUND THAT THE URINARY STIMULATION IPG HAD MIGRATED. THE URINARY STIMULATION IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Urinary Incontinence

  MAUDE report 15485555 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST-IMPLANT OF THE ANTIBACTERIAL ENVELOPE ALONG WITH AN IMPLANTABLE INTERSTIM DEVICE, THE PATIENT EXPERIENCED DISCOMFORT, SORENESS, PINCHING, ACHE, PRESSURE, SWELLING, REDNESS, WALKING DIFFICULTY, IMMOBILITY, LOSS OF BALANCE AND AN INABILITY TO GET OUT OF BED. THE ENVELOPE WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Erythema; Swelling/ Edema

  MAUDE report 15451402 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LESS THAN TWO WEEKS AFTER IMPLANT OF THE ANTIBACTERIAL ABSORBABLE ENVELOPE THE PATIENT PRESENTED TO HOSPITAL WITH HEADACHE, LIGHT SENSITIVITY, AND NAUSEA. IT WAS NOTED AT THE HOSPITAL THAT THE POCKET INCISION WAS SLIGHTLY OPEN AND THAT THE POCKET WAS INFLAMED. AN INFECTION WAS SUSPECTED. THE PAIN STIM SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Headache; Inflammation; Nausea; Unspecified Infection

  MAUDE report 14245556 ↗
• MalfunctionMar 23, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST-IMPLANT, A PIECE OF THE ANTIBACTERIAL ABSORBABLE ENVELOPE WAS NOTED TO BE PROTRUDING FROM THE POCKET SITE. THE ANTIBACTERIAL ABSORBABLE ENVELOPE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861783 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST IMPLANT WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE THE PATIENT DEVELOPED A RASH, REDNESS, AND SWELLING AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND STEROIDS. THE PHYSICIAN SUSPECTED A POSSIBLE ALLERGIC REACTION TO THE ABSORBABLE ENVELOPE. THE ABSORBABLE ENVELOPE REMAINS IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Rash

  MAUDE report 11486186 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO DAYS AFTER THE IMPLANT OF A DEVICE AND AN ABSORBABLE ENVELOPE, IT WAS NOTED THE POCKET WAS OPEN WITH THEIR IMPLANT PROTRUDING. THE PATIENT WAS SEEN IN CLINIC BY THE PHYSICIAN AND THE POCKET WAS STITCHED CLOSED AGAIN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 11123895 ↗