BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 3905288 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10628
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE TERMINAL SEGMENT OF THE LEAD WAS ANALYZED SEVERED APPROXIMATELY 15 CM FROM THE IS-1 TERMINAL PIN. VISUAL INSPECTION FOUND SETSCREW MARKS ON ALL TERMINAL CONNECTORS. THE INSULATION WAS FOUND TO HAVE ABRADED THROUGH THE RS+ COIL JUST PROXIMAL TO THE YOKE MOLDING. THE OBSERVED ABRASION IS MOST LIKELY THE RESULT OF LEAD AND DEVICE CONTACT. LABORATORY ANALYSIS CONFIRMED THE CLINICALLY OBSERVED ABRASION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE DUE TO A SUSPECTED INSULATION BREACH AT THE POCKET LEVEL. DURING EXPLORATION OF THE DEVICE POCKET, AN INSULATION BREACH WAS FOUND ON THE PACE/SENSE PORTION OF THE RV LEAD PROXIMAL TO THE YOKE. THE PROXIMAL PORTION OF THE LEAD WAS EXTRACTED STILL ATTACHED TO THE DEVICE WHICH WAS REPLACED ELECTIVELY AND THE REMAINDER OF THE LEAD CAPPED AND ABANDONED. A NEW RV LEAD AND DEVICE WERE SUCCESSFULLY IMPLANTED. INFORMATION WAS RECEIVED INDICATING THE PATIENT IS NOT PACEMAKER DEPENDENT. WHILE OVERSENSING WAS OBSERVED IN EPISODES STORED TO THE DEVICE, THERE WERE NO INSTANCES OF INAPPROPRIATE THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD ARE NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382113 ENDOTAK DSP IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 0692| 0125| F160| 1763| 1870| F102