TYRX™ CMRM6122 (UDI 00643169935891)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169935891), received between Mar 13, 2018 and Jun 7, 2019 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Expiration Issue” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION APPROXIMATELY TWO MONTHS AFTER THE IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8680568 ↗
• InjuryJul 13, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN IMPLANTED WITH AN ABSORBABLE ENVELOPE THE DEVICE SYSTEM WILL BE REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7685261 ↗
• MalfunctionJun 29, 2018Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THAT DURING AN IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT PROCEDURE AN ANTIBACTERIAL ENVELOPE WAS UTILIZED. IT WAS DISCOVERED POST IMPLANT THAT THE ENVELOPE WAS PAST THE USE BEFORE DATE (UBD). THE DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650667 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION LESS THAN TWO WEEKS AFTER THE IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) WITH AN ABSORBABLE ENVELOPE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7542135 ↗
• MalfunctionApr 27, 2018Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THE PHYSICIAN CHOSE TO IMPLANT THE ANTIBACTERIAL ENVELOPE PAST THE USE BY DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469394 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FIVE DAYS AFTER IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE POCKET WAS OPENED TO REMOVE A HEMATOMA. AT THE TIME OF THE POCKET REVISION AN ANTIBACTERIAL ENVELOPE WAS PLACED AROUND THE DEVICE. CULTURES TAKEN REVEALED NO ORGANISMS WERE IDENTIFIED. APPROXIMATELY ONE MONTH FOLLOWING THE POCKET REVISION, THE ICD AND LEADS WERE REMOVED DUE TO INFECTION. LATER, THE PATIENT RECEIVED A NEW ICD SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7456457 ↗
• MalfunctionMar 15, 2018Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THAT THE ABSORBABLE ANTIBACTERIAL ENVELOPE WAS IMPLANTED TWO DAYS AFTER IT HAD REACHED ITS USE-BY-DATE. THE PHYSICIAN WAS AWARE OF THE EXPIRED IMPLANT. THE ENVELOPE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7342349 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO INFECTION. CULTURES WERE TAKEN, AND ANTIBIOTIC TREATMENT WAS NECESSARY. IT WAS ALSO REPORTED THAT THE ANTIBIOTIC ENVELOPE WAS INFECTED, AND IT ENVELOPE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7335798 ↗