BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952420 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00110
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE UPPER CASE AND LIQUID CRYSTAL DISPLAY (LCD) WERE BROKEN. ANALYSIS ALSO FOUND THAT THE LOWER CASE AND RING COVER WERE BROKEN, THAT THE SIDE BAIL COVERS, SIDE BAILS AND RING BAIL WERE MISSING, THE LEAD FLEX COVER WAS CORRODED AND THE BATTERY CONTACTS WERE COMPRESSED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (EPG) HAD DAMAGE TO THE DISPLAY AND THE UPPER CASE. IT WAS ALSO REPORTED THE FACEPLATE IS DAMAGED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD DAMAGE TO THE DISPLAY AND THE UPPER CASE. IT WAS ALSO REPORTED THE FACEPLATE IS DAMAGED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56494 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1