BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 5785164 · Received July 12, 2016

    Report

    Report Number
    1028232-2016-02392
    Event Type
    Injury
    Date Received
    July 12, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 13, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THERE WAS A RAISED AREA OVER THE ICD SITE. THE LV LEAD WAS FOUND TO BE DISLODGED. THE RA, RV AND CRT-D WERE REVISED AT THAT TIME. IT WAS NOTED PREVIOUS POCKET WAS CLOSED AND NEW POCKET CREATED.LSO, THE CRT-D WAS REPROGRAMMED AFTER THE SYSTEM WAS REPOSITIONED. ON (B)(6) 2016 - ADDITIONAL INFORMATION: EVENT WAS DUE TO PATIENT'S TWIDDLER SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438460 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization