BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALOS SLR

    MDR report key: 2942087 · Received December 27, 2012

    Report

    Report Number
    1028232-2012-03345
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    October 9, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    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 - IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER DRAINED EARLIER THAN EXPECTED. THIS IS ALL OF THE INFO PROVIDED. IF ADD'L INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALOS SLR PACEMAKER NVZ BIOTRONIK SE & CO. KG. 689585

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization