BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC ENERGEN ICD E142

    MDR report key: 13543806 · Received February 15, 2022

    Report

    Report Number
    MW5107507
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    February 9, 2022
    Report Date
    February 14, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPOTAION
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ERROR CODE 1003. VOLTAGE IS LOO LOW FOR PROJECTED REMAINING CAPACITY. BOSTON SCIENTIFIC RECOMMENDED 90 DAY POSSIBLE CHANGE OUT.

    Description of Event or Problem · 0

    ERROR CODE 1003. VOLTAGE IS LOO LOW FOR PROJECTED REMAINING CAPACITY. BOSTON SCIENTIFIC RECOMMENDED 90 DAY POSSIBLE CHANGE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390125 BOSTON SCIENTIFIC ENERGEN ICD E142 IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPOTAION E142

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other