BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151553 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00506
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. HOWEVER, IT WAS NOTED THAT THE UPPER CASE WAS BROKEN AND CONTAMINATED, THE LOWER CASE WAS BROKEN AND CONTAMINATED, THE BATTERY RELEASE WAS CONTAMINATED, TWO SIDE BAIL COVERS WERE BROKEN, THE LEAD FLEX COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE BATTERY DRAWER WAS BROKEN, AND THE DISPLAY WAS OUT OF SPECIFICATION WITH PIXEL SEGMENTS MISSING.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE IS LOCKED UP. THE DEVICE WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252327 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1