BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 53

    MDR report key: 2040036 · Received March 25, 2011

    Report

    Report Number
    1028232-2011-00692
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P980037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE REVISING THE LV LEAD DUE TO TWIDDLER'S SYNDROME, THIS ATRIAL LEAD WAS CAPPED BECAUSE IT WAS NOT WORKING APPROPRIATELY. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACING LEAD NVZ BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR