BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPAZ II

    MDR report key: 1921353 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05740
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 2, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 HAS A MAGNET RATE OF 75 BPM. THE CALLER WAS CONCERNED THAT THE DEVICE, WHICH HAS BEEN IMPLANTED ALMOST TEN YEARS, COULD BE AT END OF BATTERY LIFE (EOL). THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOPAZ II IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 520E ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other (B)(4) IMPLANTABLE PACING LEAD