TYRX™ CMRM6133 (UDI 00763000101619)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00763000101619), received between Jul 11, 2018 and Mar 3, 2023 — classified as 47 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT RETURNED FOR FOLLOW-UP WITH A FEVER AND WAS ADMITTED TO THE HOSPITAL. THE INFRACLAVICULAR INCISION ON THE RIGHT WAS EXPLORED, DEBRIDED AND RECLOSED BUT DID NOT APPEAR TO BE SIGNIFICANTLY INFECTED. THE PATIENT ALSO HAD CHILLS AND PURULENT, BLOODY DRAINAGE AT THE INCISION SITE. THE SITE HAD PREVIOUSLY BEEN CLEANED AND RE-DRESSED IN OFFICE. THE PATIENT WAS TREATED WITH ANTIBIOTICS. TISSUE CULTURES SHOWED A FEW STAPHYLOCOCCUS AUREUS. ADDITIONAL INFORMATION RECEIVED INDICATED AN ANTIBACTERIAL ABSORBABLE ENVELOPE HAS BEEN USED DURING THE IMPLANT OF THE CRT-D APPROXIMATELY TWO WEEKS PRIOR. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Chills; Fever; Purulent Discharge; Unspecified Infection

  MAUDE report 16476745 ↗
• MalfunctionJun 24, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SYSTEM EXPLANT PROCEDURE, IT WAS NOTED THAT THE MESH OF THE ABSORBABLE ENVELOPE WAS STILL PARTIALLY REMAINING, AFTER NEARLY ONE YEAR IMPLANTED IN THE PATIENT. THE REMAINING MESH WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059061 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A POCKET REVISION WAS PERFORMED APPROXIMATELY THREE WEEKS POST IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WITH AN ABSORBABLE ENVELOPE AS THE DEVICE SITE WOUND WAS NOT HEALING. APPROXIMATELY THREE WEEKS AFTER POCKET REVISION, WHEN THE PATIENT WAS SEEN IN CLINIC, THE SITE BANDAGE WAS REMOVED AND THE DEVICE WAS VISIBLE THROUGH A HOLE IN THE INCISION. THE DEVICE SYSTEM WAS EXPLANTED DUE TO INFECTION AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. IT WAS FURTHER REPORTED THAT DURING INTERROGATION OF THE DEVICE FOR EXTRACTION, THE LEFT VENTRICULAR (LV) LEAD WAS REPORTED TO HAVE HIGH THRESHOLDS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10417437 ↗
• InjuryJul 9, 2020Adverse 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) SYSTEM THAT WAS IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS EXPLANTED DUE TO A POCKET INFECTION. CULTURES WERE TAKEN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10250234 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT A ANTIBACTERIAL ABSORBABLE ENVELOPE WAS IN USE AT THE TIME OF THE INFECTION. THE ANTIBACTERIAL ABSORBABLE ENVELOPE WAS REMOVED AT THE SAME TIME THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXTRACTED.

  Patient problems: Unspecified Infection

  MAUDE report 10163701 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ONE MONTH POST IMPLANT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH AN ABSORBABLE ENVELOPE. THE ICD SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10048477 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A DEVICE INFECTION APPROXIMATELY SIX WEEKS AFTER THE IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH AN ABSORBABLE ENVELOPE. THE CRT-D SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10030383 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET INFECTION, POCKET HEMATOMA, OPEN INCISION, BRUISING AND PAIN APPROXIMATELY FIVE WEEKS AFTER A REVISION PROCEDURE INVOLVING THE IMPLANT OF AN ABSORBABLE ENVELOPE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bruise/Contusion; Hematoma; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 10009237 ↗
• InjuryApr 23, 2020Adverse 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) SYSTEM THAT WAS IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE WAS EXPLANTED DUE TO AN INFECTION. A HEMATOMA DEVELOPED A FEW DAYS EARLIER. THEN THE PATIENT EXPERIENCED A FEVER AND OOZING AT THE INCISION SITE. ANTIBIOTIC TREATMENT WAS PROVIDED AND CULTURES WERE TAKEN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Hematoma; Unspecified Infection

  MAUDE report 9992038 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT A ANTIBACTERIAL ABSORBABLE ENVELOPE HAD BEEN UTILIZED WHEN THE PATIENT EXPERIENCE THE INFECTION AND EROSION. THE ANTIBACTERIAL ABSORBABLE ENVELOPE WAS REMOVED AT THE SAME TIME THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXTRACTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 9978453 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGE IN WHICH A LARGE ABSORBABLE ANTIBACTERIAL ENVELOPE WAS USED. THE PATIENT DEVELOPED SWELLING OVER THE ICD POCKET SOON AFTER THE DEVICE CHANGE. THE ICD SYSTEM WAS REMOVED DUE TO AN INFECTION. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS IMMEDIATELY AT FIRST SIGNS OF INFECTION AND AFTER DEVICE SYSTEM REMOVAL. THE ICD SYSTEM WAS NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 9860579 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT A DEVICE CHECK, THE INCISION SITE HAD AN ODOR AND SUPERFICIAL GREENISH DISCHARGE INDICATING AN INFECTION OF THE SURGICAL INCISION SITE. THE INFECTION OCCURRED FOUR WEEKS AFTER THE IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH AN ABSORBABLE ENVELOPE. THE PATIENT WAS GIVEN ANTIBIOTICS AND THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9812091 ↗
• InjuryJan 9, 2020Adverse 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 THREE WEEKS AFTER IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE ICD SYSTEM WILL BE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9572385 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SEVEN WEEKS POST IMPLANT THE ABSORBABLE ANTIBACTERIAL ENVELOPE WAS REMOVED WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM DUE TO AN INFECTION. THE ICD SYSTEM WAS NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9570048 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING GENERATOR REPLACEMENT AND ADDITION OF AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT DEVELOPED CHRONIC POCKET PAIN AND A SKIN PUSTULE OVER THE DEVICE POCKET. AN INFECTION OF THE DEVICE POCKET WAS IDENTIFIED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND THE PATIENT TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9548620 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A ANTIBACTERIAL ABSORBABLE ENVELOPE AND COMPETITOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD DEVELOPED AN INFECTION / BACTEREMIA. CULTURES WERE TAKEN AND ANTIBIOTIC TREATMENT WAS NECESSARY. A BLOOD TEST REVEALED HIGH WHITE BLOOD CELL (WBC) AND THE PATIENT WAS DIAGNOSED WITH INFECTION AND GROWTH ON LEAD(S) AS WELL AS FLORA ON VALVE. IT WAS NOTED THAT IT IS UNKNOWN IF THE INFECTION STARTED AT THE ICD POCKET OR WAS A LONG STANDING ISSUE DUE TO GROWTH ON VALVE THAT MAY HAVE PRECEDED DEVICE IMPLANT. THE ANTIBACTERIAL ABSORBABLE ENVELOPE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9513183 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR-MONTH POST REPLACEMENT PROCEDURE WERE AN ABSORBABLE ANTIBACTERIAL ENVELOPE WAS USED, THE PATIENT DEVELOPED A ¿POSSIBLE INFECTION¿. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9370986 ↗
• InjuryNov 20, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION FOUR WEEKS AFTER THE IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH AN ABSORBABLE ENVELOPE. THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9350349 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) LEAD AND ANTIBACTERIAL ABSORBABLE ENVELOPE THE PATIENT PRESENTED WITH DRAINAGE AND OOZING AT THE DEVICE POCKET SITE. THE PATIENT IS BEING TREATED WITH ANTIBIOTICS. THE ICD SYSTEM AND ANTIBACTERIAL ABSORBABLE ENVELOPE REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9316403 ↗
• InjuryNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 DAYS AFTER IMPLANT, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REMOVED FROM THE POCKET TO DRAIN A HEMATOMA. THE DEVICE WAS PLACED BACK IN THE POCKET WITH A ANTIBACTERIAL ABSORBABLE ENVELOPE. THE PATIENT CONTINUED TO HAVE PROBLEMS WITH THE POCKET. IT WAS DECIDED AFTER A POCKET EVALUATION THAT THE DEVICE AND LEADS WOULD BE REMOVED TO ALLOW THE POCKET TO HEAL. IT WAS NOTED THAT THE TISSUE IN THE POCKET APPEARED TO BE DISCOLORED AND POSSIBLE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9306932 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT REPORTED REDNESS AT THE INCISION SITE THAT WAS WARM TO THE TOUCH WITH PURULENT DRAINAGE. A SMALL OPEN AREA WAS NOTED. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THE INCISION WAS LATER NOTED TO BE HEALED. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 9262845 ↗
• InjuryOct 11, 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 IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH AN ABSORBABLE ENVELOPE. THE DEVICE AND LEADS WERE EXPLANTED AND WILL BE REPLACED IN THE FUTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9182688 ↗
• MalfunctionSep 26, 2019Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT A ANTIBACTERIAL ABSORBABLE ENVELOPE WAS IMPLANTED THAT WAS POST ITS INDICATED USE BEFORE DATE (UBD). THE DEVICE 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 9125833 ↗
• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A REVISION PROCEDURE IN WHICH A ANTIBACTERIAL ABSORBABLE ENVELOPE WAS IMPLANTED THE PATIENT DEVELOPED AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXTRACTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9125682 ↗
• InjuryAug 23, 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 WITHIN TWO WEEKS POST-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 8924627 ↗