BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 18640043 · Received February 5, 2024

    Report

    Report Number
    2124215-2024-06190
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    January 12, 2024
    Report Date
    April 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO FIELD H6 IMPACT CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALSO HAS A LEFT VENTRICULAR ASSIST DEVICE (LVAD) EXPERIENCED NON-CONVERSION WITH THEIR CURRENT PROGRAMMED SETTINGS. THE PATIENT RECEIVED 8 SHOCKS FOR VENTRICULAR FIBRILLATION (VF) AND HAD TO BE EXTERNALLY RESCUED. DURING THE GENERATOR CHANGE OUT IT WAS NOTED THAT SHOCK LEAD IMPEDANCES WERE NOTED TO BE HIGH, OUT-OF-RANGE MEASURING 150-190 OHMS. A CODE 1005 WAS RECORDED, INDICATIVE OF AN OPEN CIRCUIT CONDITION DETECTED UPON SHOCK DELIVERY DUE TO HIGH, OUT-OF-RANGE IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES RECOMMENDED LEADS REPLACEMENT AND TROUBLESHOOTING OPTIONS. SURGICAL INTERVENTION WAS PERFORMED AND WHEN THE POCKET WAS OPENED THERE WERE OBSERVATIONS OF PUSS WHICH INDICATES THERE WAS AN INFECTION. SUBSEQUENTLY, THE DEVICE AND RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALSO HAS A LEFT VENTRICULAR ASSIST DEVICE (LVAD) EXPERIENCED NON-CONVERSION WITH THEIR CURRENT PROGRAMMED SETTINGS. THE PATIENT RECEIVED 8 SHOCKS FOR VENTRICULAR FIBRILLATION (VF) AND HAD TO BE EXTERNALLY RESCUED. DURING THE GENERATOR CHANGE OUT IT WAS NOTED THAT SHOCK LEAD IMPEDANCES WERE NOTED TO BE HIGH, OUT-OF-RANGE MEASURING 150-190 OHMS. A CODE 1005 WAS RECORDED, INDICATIVE OF AN OPEN CIRCUIT CONDITION DETECTED UPON SHOCK DELIVERY DUE TO HIGH, OUT-OF-RANGE IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES RECOMMENDED LEADS REPLACEMENT AND TROUBLESHOOTING OPTIONS. SURGICAL INTERVENTION WAS PERFORMED AND WHEN THE POCKET WAS OPENED THERE WERE OBSERVATIONS OF PUSS WHICH INDICATES THERE WAS AN INFECTION. SUBSEQUENTLY, THE DEVICE AND RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274280 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0185 332365

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Hospitalization| R