BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1711477 · Received June 3, 2010

    Report

    Report Number
    MW5016158
    Event Type
    Injury
    Date Received
    June 3, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED THREE DEVICE SHOCKS SEVERAL DAYS BEFORE (B) (6) 2010 THAT WERE DEEMED INAPPROPRIATE THERAPIES. ON INTERROGATION, THE ICD PULSE GENERATOR INDICATOR SHOWED THAT THE DEVICE HAD REACHED ITS PREMATURE END OF SERVICE BECAUSE OF A PRESUMED INTERNAL COMPONENT FAILURE. IT WAS FOUND THAT A MICRO FRACTURE OF OUTER INSULATION OF HIGH ENERGY ICD LEAD. NEW GENERATOR PLACED AND AT A 4 WEEK FOLLOWUP VISIT, PT IS WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC COGNIS NIK BOSTON SCIENTIFIC N119 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization CHRONIC RA LEAD: SJM 3 1488, (B) (4)| CHRONIC LV CS LEAD: SJM MN 1056, (B) (4)| CHRONIC RV LEAD: SMJ # 1559, (B) (4)