BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3061780 · Received April 16, 2013

    Report

    Report Number
    2124215-2013-06283
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    February 11, 2013
    Report Date
    September 26, 2018
    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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED THE LEAD WAS RETURNED IN TWO SEGMENTS; THE TERMINAL SEGMENT WAS SEVERED 38 CM FROM THE IS-1 TERMINAL PIN. IN ADDITION, CALCIFICATION WAS OBSERVED ON THE DISTAL AND PROXIMAL SHOCKING COILS AND THE INSULATION WAS ABRADED THROUGH TO THE RATE-SENSE COILS PROXIMAL TO THE DISTAL SHOCKING COILS. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED STRESS OVER TIME. IN THIS CASE, WE BELIEVE THE STRESS WAS THE RESULT OF LEAD CONTACT WITH ANOTHER LEAD. THE REPORTED HIGH IMPEDANCE MEASUREMENTS ARE LIKELY THE RESULT OF THE LEAD DAMAGE OBSERVED BY THE LABORATORY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS PATIENT'S HOME MONITORING SYSTEM DETECTED A HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT, AT THIS TIME, THE PATIENT WILL CONTINUE TO BE MONITORED THROUGH THE REMOTE MONITORING SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THIS LEAD WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163026 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R E141| T175| 0185