BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2812498 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01919
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE BATTERY DOOR HADN'T REMAIN CLOSED. THE BIOMED REPAIRED THE BATTERY DOOR. IT WAS ALSO REPORTED THE LCD (LIQUID CRYSTAL DISPLAY) HAD SMUDGES. THE BIOMED COMPLAINED THAT THE RING AND PLASTIC PIECE TO HOLD IT IN PLACE COULDN'T BE ORDERED DUE TO THE PARTS BEING OUT OF STOCK. THE DEVICE IS BEING RETURNED FOR CALIBRATION AND SERVICE. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other