BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE

    MDR report key: 1890298 · Received November 3, 2010

    Report

    Report Number
    6000094-2010-02124
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 2, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S032
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PEDIATRIC EP THAT A POWER-ON-RESET OCCURRED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS PACEMAKER DEPENDENT AND HAD AN ARREST POST DEVICE RESET. THE PHYSICIAN IMPLANTED A NEW DEVICE AND WILL EXPLANT THE OLD DEVICE LATER (IT NEEDS SURGERY TO EXTRACT). 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. E2DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R