TYRX™ CMRM6122 (UDI 00763000101602)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000101602), received between Sep 11, 2018 and Nov 4, 2020 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTERIAL INFECTION. CULTURES WERE TAKEN AND MICRO COCCUS BACTERIUM WAS CONFIRMED AND ANTIBIOTICS WERE ADMINISTERED. VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD WAS CONFIRMED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM INCLUDING TYRX ENVELOPE WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 10786007 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD ERODED THROUGH THE POCKET AND BECOME EXPOSED. THE CRT-D SYSTEM, WHICH HAD BEEN IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE, WAS REMOVED DUE TO THE RISK OF INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WILL RECEIVE A NEW SYSTEM AT A FUTURE DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 9404882 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION APPROXIMATELY ONE MONTH AFTER A DEVICE CHANGEOUT WHICH INCLUDED PLACEMENT OF AN ABSORBABLE ENVELOPE. ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9193794 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DEVICE POCKET INFECTION WHICH HAD BEEN IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. IT WAS NOTED THAT INFECTION WAS A "CHRONIC PROBLEM WITH THIS PATIENT." THE ORGANISM WAS IDENTIFIED AS (B)(6). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED AND WILL NOT BE REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9104965 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST IMPLANT PROCEDURE WERE AN ABSORBABLE ANTIBACTERIAL ENVELOPE WAS USED, THE PATIENT POCKET ERODED. THE PHYSICIAN NOTED THAT THE ENVELOPE COULD HAVE PLAYED A ROLE IN THE DEVICE ERODING FROM THE INCISION. IT WAS NOTED THAT APPROXIMATELY TWO MONTHS PRIOR TO THE DEVICE ERODING, THE INCISION WAS DRAINING SEROSANGUINOUS FLUID AND THE PATIENT WAS ADVISED TO USE ANTIBIOTIC OINTMENT. THE CRT-P SYSTEM WAS EXPLANTED AND REPLACED DUE TO A POTENTIAL RISK OF INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 8841638 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SKIN IN THE AREA OF THE INCISION WAS NOT HEALING, WITH PUS DRAINAGE AND POSSIBLE INFECTION NOTED. THE PHYSICIAN OPTED TO EXPLANT THE ENTIRE SYSTEM BEFORE THE PATIENT BECAME SYMPTOMATIC. THE PHYSICIAN COMMENTED THAT THE POCKET LOOKED GOOD WITH NO SIGNS OF INFECTION, AND THE ISSUE SEEMED TO BE ISOLATED TO THE INCISION AREA. THE PATIENT ALSO REPORTED INFECTION. A REPLACEMENT SYSTEM WAS IMPLANTED A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 8800993 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8709413 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT ONLY THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. THE ANTIBACTERIAL ABSORBABLE ENVELOPE HAD ALREADY BEEN ABSORBED AND WAS NOT EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 8599213 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIXTY DAYS POST A LEAD REVISION PROCEDURE THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD ERODED TO THE SURFACE OF THE SKIN. IT WAS NOTED THAT AT THE TIME OF THE REVISION A ANTIBACTERIAL ABSORBABLE ENVELOPE WAS IMPLANTED. THE ICD SYSTEM AND LEADS HAVE BEEN EXTRACTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 8591143 ↗
• InjuryApr 22, 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, WITH PUS COMING FROM THE POCKET. THE ENTIRE SYSTEM WAS EXPLANTED, WITH ANTIBIOTIC TREATMENT PROVIDED. THE SYSTEM WAS LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8538007 ↗
• InjuryMar 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM HAD A POCKET INFECTION APPROXIMATELY TWO MONTHS AFTER BEING IMPLANTED. THE IPG SYSTEM, WHICH WAS INITIALLY IMPLANTED WITHIN AN ABSORBABLE ENVELOPE, WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8408587 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS IMPLANT INCISION DID NOT HEAL AND THE PATIENT DEVELOPED AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXTRACTED. IT WAS NOTED THAT A ANTIBACTERIAL ABSORBABLE ENVELOPE WAS INITIALLY IMPLANTED WITH THE ICD SYSTEM. CULTURES WERE TAKEN AND ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 8373861 ↗
• MalfunctionFeb 11, 2019Use of Device Problem; Expiration Date Error; Use of Device Problem; Expiration Date Error

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE AN ABSORBABLE ENVELOPE WAS IMPLANTED ONE DAY PAST ITS EXPIRATION DATE. THE ABSORBABLE 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 8325332 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A POCKET INFECTION AFTER A RECENT IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT PROCEDURE WHERE A ABSORBABLE ANTIBACTERIAL ENVELOPE HAD BEEN UTILIZED. THE IPG AND LEADS HAVE BEEN EXTRACTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8134232 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8030361 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW DAYS AFTER IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM AND ANTIBACTERIAL ENVELOPE, THERE WAS ITCHING, REDNESS, INFLAMMATION AT THE IMPLANT SITE, AND THERE WAS OOZING THROUGH THE SKIN. THE PHYSICIAN FELT THERE WAS A POSSIBLE ALLERGIC REACTION TO THE ANTIBACTERIAL ENVELOPE. INFECTION WAS ALSO REPORTED AND TESTING FOR THIS WAS DONE. THE IPG SYSTEM AND THE ENVELOPE WERE REMOVED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE AND IT WAS LEARNED THAT TESTING SHOWED THE PATIENT DID NOT HAVE AN INFECTION. ADDITIONALLY, TESTING WAS DONE BY PLACING TWO SUBSTANCES ON THE OPPOSITE SIDE OF THE PATIENT'S CHEST AND THE PATIENT RESPONDED WITH THE SAME SYMPTOMS. THE PHYSICIAN DETERMINED THE PATIENT WAS NOT ALLERGIC TO THE ANTIBACTERIAL ENVELOPE, BUT WAS IN FACT ALLERGIC TO THE BENZOIN AND MATISOL THAT WAS APPLIED TO THE SKIN AT THE TIME OF IMPLANT. THE PATIENT MAY BE IMPLANTED WITH A LEAD LESS PACEMAKER IN THE FUTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Inflammation; Itching Sensation; Unspecified Infection

  MAUDE report 7930983 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET INFECTION APPROXIMATELY ONE MONTH POST IMPLANT THE IMPLANTABLE PULSE GENERATOR ( IPG) SYSTEM WITH AN ABSORBABLE ENVELOPE. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7863629 ↗