BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 2844893 · Received November 2, 2012

    Report

    Report Number
    1028232-2012-02682
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    August 16, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - THERE WAS A LOT OF NOISE DETECTION AND THE DEVICE CHARGED INAPPROPRIATELY MANY TIMES. BECAUSE OF THIS THE DEVICE BATTERY PREMATURELY DRAINED. A NEW LEAD AND A NEW DEVICE WERE IMPLANTED. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization