BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3953813 · Received July 23, 2014

    Report

    Report Number
    2124215-2014-14295
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT EXPECTED TO BE RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S HOME MONITORING EQUIPMENT DETECTED RECURRENT ALERTS FOR HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE CAUSES AND PROVIDED TROUBLESHOOTING OPTIONS. A REVISION PROCEDURE WAS PERFORMED WHERE THE PHYSICIAN TRIED TO REINSERT THE RV LEAD INTO THE HEADER AND THE SHOCK IMPEDANCE WAS STILL HIGH AND OUT OF RANGE. FLUOROSCOPY DID NOT REVEAL ANY ISSUES WITH THE LEAD, HOWEVER A FRACTURE WAS SUSPECTED BUT NOT CONFIRMED. THE ICD REMAINS IN SERVICE AND THE RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431216 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R T165| E110| 4469| 0184