BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 53

    MDR report key: 2943494 · Received January 9, 2013

    Report

    Report Number
    1028232-2013-00014
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 27, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH THRESHOLD READINGS AND OUT OF RANGE IMPEDANCES. THERE WERE NO ADVERSE PT EVENTS REPORTED. SHOULD ADD'L INFO BE REC'D, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12871 SELOX ST 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 346366

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization