BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212912 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08801
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 3, 2013
    Report Date
    March 30, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    TO DATE, THE LEAD REMAINS IN SERVICE AND WILL NOT BE RETURNED AND WILL NOT UNDER GO DETAILED ANLAYSIS THEREFORE A ROOT CAUSE CAN NOT BE DETERMINED FOR THE LEAD. WHILE THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECIEPT THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT FOR THE EXPLANTED DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD WAS EXPLANTED NEARLY THREE YEARS LATER AS THE PATIENT HAD A HEART TRANSPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD REVEALED HIGH SHOCK IMPEDANCES GREATER THAN 200 OHMS. THE SHOCK IMPEDANCE TRENDS REVEALED A SHARP RISE IN (B)(6) OF 2012 AND HAVE BEEN HIGH EVER SINCE. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS WHILE THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312862 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| L| R 6945| (B)(4)| (B)(4)| MISMATCH| (B)(4)| 5076| 4543| 4266