BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTION AFM

    MDR report key: 1861530 · Received October 8, 2010

    Report

    Report Number
    6000094-2010-01860
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 9, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S3
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET UPON INTERROGATION. THE DEVICE HAS ALSO REACHED DEPLETION. THE DEVICE WAS REPORGRAMMED WITH A LOWER OUTPUT. THE DEVICE WAS REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD HAD HIGH IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTION AFM IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 902 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention IMK49B IMPLANTABLE PACING LEAD