BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2811534 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01896
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT OF A GENERATED ERROR WHICH WAS SUBSEQUENTLY ABLE TO BE CLEARED. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE BROKEN, THE BATTERY RELEASE CONTAMINATED,THE SIDE BAIL COVERS AND SIDE BAILS MISSING AND THE KEYBOARD WAS SCRATCHED. THE DEVICE WAS TO BE SCRAPPED IN-HOUSE.

    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 A SELF TEST ERROR DISPLAYED ON THE SCREEN. ERROR CLEARED WHEN THE BATTERY WAS REMOVED. THE DEVICE REMAINS IN SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE HAD NOW BEEN RETURNED AS PART OF A TRADE-IN PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other