BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX SR 53

    MDR report key: 2190087 · Received June 29, 2011

    Report

    Report Number
    1028232-2011-01444
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 21, 2011
    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 - AFTER AN IMPLANTATION TIME OF ABOUT 26 MONTHS, A SUSPECTED LEAD FRACTURE WAS REPORTED BY THE PHYSICIAN. HOWEVER, ALL MEASUREMENT VALUES WERE NORMAL. THE LEAD WAS EXPLANTED. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX SR 53 PACER LEAD NVZ BIOTRONIK, SE & CO KG 343083

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization