TYRX™ NMRM6133 (UDI 00763000307905)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000307905), received between Oct 21, 2021 and Oct 4, 2024 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AFTER IMPLANT, THE PATIENT EXPERIENCED A HOLE IN THE WOUND AT THE IMPLANT SITE OF THE DEVICE WHERE AN ABSORBABLE ANTIBACTERIAL ENVELOPE WAS USED. IT WAS NOTED BY THE PATIENT'S PHYSICIAN THAT THERE WERE NO SIGNS OF INFECTION. THE POCKET WAS RE-OPENED, A WASHOUT WAS PERFORMED, AND A NEW ENVELOPE WAS PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 20374187 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER CLARIFIED THE PATIENT BEGAN TO EXPERIENCE ACUTE, INTENSE PAIN AND SWELLING AT THE IMPLANT SITE SHORTLY AFTER THE IMPLANT OF THE SCS SYSTEM. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. UPON EXPLANT OF SCS SYSTEM, FIBROUS MATERIAL WAS NOTED WHICH THE PHYSICIAN SUSPECTED TO BE REMNANTS OF THE ANTIBACTERIAL ABSORBABLE ENVELOPE. THE PATIENT'S SKIN OVER THE INCISION SITE HAS BECOME "TISSUE-PAPER" THIN.

  Patient problems: Chills; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16528097 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH POST-IMPLANT OF AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE INCISION SITE DEVELOPED AN INFECTION. ANTIB IOTIC TREATMENT WITH WOUND CARE WAS NECESSARY, AND THE ANTIBACTERIAL ABSORBABLE ENVELOPE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15666669 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SEVEN WEEKS POST-IMPLANT OF AN ANTIBACTERIAL ABSORBABLE, THE PATIENT DEVELOPED REDNESS AT THE POCKET SITE. THE PHYSICIAN DETERMINED THAT THE PATIENT HAD AN INFECTION, AND THE ANTIBACTERIAL ABSORBABLE ENVELOPE WAS REMOVED. ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 15257876 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NEUROSTIMULATION SYSTEM FOR CONTROLLING PAIN WAS REMOVED DUE TO INFECTION. IT WAS FURTHER REPORTED THAT A TYRX SLEEVE WAS USED AT THE TIME OF THE SYSTEM IMPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12672465 ↗