BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152328 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00684
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE UPPER CASE WAS BROKEN/CONTAMINATED, LOWER CASE WAS BROKEN/CONTAMINATED, BATTERY DRAWER WAS BROKEN, AND BATTERY DRAWER O-RING WAS MISSING. IT WAS ALSO NOTED THAT THE BATTERY RELEASE WAS CONTAMINATED, TWO SIDE BAIL COVERS WERE BROKEN, THE RING COVER WAS CONTAMINATED, THE LEAD FLEX COVER WAS BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT AND THE BATTERY FLEX WAS CONTAMINATED.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT THE EXTERNAL PULSE GENERATOR (EPG) NEEDED REPAIR OF THE BATTERY DRAWER AND THE O-RING. IT WAS ALSO NOTED THAT THE FRONT AND BACK CASE HAVE CRACKS. THE EPG WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252916 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1