BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2811132 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-02044
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 28, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL TESTING. IT WAS NOTED THAT THE UPPER CASE WAS DENTED CAUSING THE KEYBOARD TO NOT LIE PROPERLY, THE UPPER CASE WAS CONTAMINATED, THE LOWER CASE WAS BROKEN AND CONTAMINATED, ONE KNOB WAS BROKEN, THE RING BAIL WAS BENT, THE BATTERY DRAWER WAS BROKEN, THE KEYBOARD WAS SCRATCHED, THE BATTERY RELEASE AND RING COVER WERE CONTAMINATED, ONE CASE SCREW WAS MISSING, THE BATTERY CONTACTS WERE COMPRESSED AND DENTED AND THE SIDE BAIL COVERS WERE BROKEN.

    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 EXTERNAL PULSE GENERATOR HAD INTERMITTENT OUTPUT. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD INTERMITTENT OUTPUT. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    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