BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE

    MDR report key: 1922221 · Received December 13, 2010

    Report

    Report Number
    6000094-2010-02196
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S030
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LEAD LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS HAVING LITHOTRIPSY PROCEDURE, THE PATIENT WENT INTO ASYSTOLE AND WHEN A MAGNET WAS APPLIED IT SEEMED TO HAVE NO EFFECT ON THE DEVICE. AFTER THE PROCEDURE, THE DEVICE RETURNED TO NORMAL FUNCTION AND IT WAS QUESTIONED IF THIS COULD HAVE BEEN CAUSED BY A LEAD ISSUE. THE DEVICE AND LEAD ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. E2SR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention