BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PX 60 BP

    MDR report key: 2140359 · Received June 17, 2011

    Report

    Report Number
    1028232-2011-01311
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 3, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS FUNCTIONING, HOWEVER, HAD A CHRONIC HIGH PACING THRESHOLD. UNDER FLUOROSCOPY, THE LEAD DID NOT HAVE ANY SLACK. THEREFORE, THE LEAD WAS CAPPED AND REPLACED. THERE WERE NO ADVERSE PT EFFECTS REPORTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PX 60 BP PACER LEAD NVZ BIOTRONIK SE & CO. KG 119687

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization