BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTRONIK

    MDR report key: 6202068 · Received December 21, 2016

    Report

    Report Number
    MW5066874
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    December 13, 2016
    Report Date
    December 21, 2016
    Manufacturer
    BIOTRONIK
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN ICD LEAD LASER EXTRACTION AND REPLACEMENT AND GENERATOR CHANGE TO REPAIR A LEAD FRACTURE ON A LEAD PLACED ON (B)(6) 2012. GENERATOR WITH 19% BATTERY LIFE. DURING THE EXTRACTION PROCESS, THE PT DEVELOPED AN AVULSION OF THE SVC/RA AND ALL ALONG THE INNOMINATE VEIN. EMERGENCY STERNOTOMY PERFORMED WITH CELL SAVER AND MULTIPLE TRANSFUSIONS. DESPITE AGGRESSIVE TREATMENT, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845231 BIOTRONIK ICD LEAD LWS BIOTRONIK LENOX SMART TD6516
    845232 GLIDELIGHT GLIDELIGHT LASER SHEATH MFA SPECTRANETICS FGC16H03A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death