BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151604 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00500
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 CONFIRMED THE REPORTED EVENT, THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN. IT WAS ALSO NOTED THAT THE UPPER CASE, LOWER CASE AND SIDE BAIL COVERS WERE BROKEN, THE RING COVER AND BATTERY DRAWER WERE CONTAMINATED, AND THE RING WAS BENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE OUTPUT CONNECTOR ON THE EXTERNAL PULSE GENERATOR (EPG) IS BROKEN. THE EPG 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
    252277 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1