BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 3871896 · Received June 13, 2014

    Report

    Report Number
    1028232-2014-01992
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    March 21, 2014
    Report Date
    June 3, 2014
    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.

    Description of Event or Problem · 1

    THERE WAS A POCKET AND LEAD REVISION DONE FOR THIS PATIENT BECAUSE THE DEVICE HAD MOVED THE DAY AFTER IMPLANT AND THE PATIENT WAS UNCOMFORTABLE. THE PHYSICIAN MOVED THE DEVICE AND RE-SUTURED IT. BOTH LEADS WERE GIVEN ADDITIONAL SLACK AND WERE SUTURED AGAIN AS WELL. THIS SYSTEM REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349685 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization