BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3936016 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13805
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED IN THREE SEGMENTS. VISUAL INSPECTION OF THE LEAD NOTED EXTENSIVE DAMAGE RELATED TO THE EXPLANT PROCEDURE INCLUDING STRETCHING, CUTS, TEARS, PUNCTURES, AND INSULATION SEPARATION. BLOOD/BODY FLUID WAS ALSO FOUND INSIDE THE LEAD LUMENS. CONTINUITY TESTING WAS PERFORMED ON EACH OF THE LEAD SEGMENTS, ALL OF WHICH PASSED. MICROSCOPIC INSPECTION NOTED TRILUMEN INSULATION DAMAGE 325-332MM FROM THE TERMINAL PIN. THE INSULATION ALSO EXHIBITED WEBBING DAMAGE IN THIS AREA BETWEEN THE RS- AND DISTAL HV LUMENS. DUE TO THE LOCATION AND TYPE OF DAMAGE OBSERVED, IT WAS CONCLUDED IT WAS LIKELY CAUSED BY CLAVICLE/FIRST-RIB ENTRAPMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT HAS BEEN RETURNED FOR ANALYSIS AND THIS REPORT WILL BE UPDATED UPON ITS COMPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A 41 J SHOCK FOR VENTRICULAR TACHYCARDIA (VT) WHICH TERMINATED THE EPISODE. NOISE AND OVERSENSING WERE OBSERVED ON BOTH THE RIGHT VENTRICULAR (RV) AND UNKNOWN RIGHT ATRIAL (RA) LEADS FOLLOWING DELIVERY OF THE SHOCK, NO PACING INHIBITION OR ASYSTOLE WAS REPORTED. THE MEASURED SHOCK IMPEDANCE WAS 26 OHMS AND AN INSULATION DEFECT OF THE RV LEAD WAS SUSPECTED. IT WAS FURTHER REPORTED THAT SHOCK IMPEDANCE MEASUREMENTS HAD BEEN INTERMITTENTLY LOW FOR SEVERAL MONTHS AND CHRONICALLY LOW FOR APPROXIMATELY ONE MONTH PRIOR TO THE EVENT. SUBSEQUENTLY, AN OPEN HEART REVISION PROCEDURE WAS PERFORMED WHEREIN THE RV LEAD AND ICD WERE EXPLANTED IN ADDITION TO PORTIONS OF PREVIOUSLY ABANDONED LEADS OF UNKNOWN ORIGIN. THE PATIENT IS EXPECTED TO BE REIMPLANTED WITH A NEW SYSTEM IN A FUTURE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD AND RV LEAD ARE NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413966 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R F102| 0175