BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 3984483 · Received August 6, 2014

    Report

    Report Number
    1028232-2014-002780
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 24, 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

    THIS LEAD WAS EXPLANTED AND REPLACED THE DAY AFTER IMPLANT. THE LEAD HAD DISLODGED AND THE PHYSICIAN TRIED TO REPOSITION IT BUT IT KEPT FALLING OUT AND DIDN'T HAVE VERY GOOD THRESHOLD NUMBERS. THE HELIX WAS ALSO STARTING TO GIVE THE PHYSICIAN TROUBLE. THE PHYSICIAN DECIDED TO IMPLANT A NEW LEAD. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459749 SETROX S 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization