BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991590 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-00985
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH 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 CONFIRMED THE REPORTED EVENT, THE DISPLAY WAS "BLEEDING" PIXELS AND THE UPPER AND LOWER CASES WERE BROKEN, COULD NOT CONFIRM THE SELF-TEST FAILURE HOWEVER THE DEVICE DID FAIL FUNCTIONAL TESTING DUE TO THE DEVICE WOULD NOT POWER UP. IT WAS ALSO NOTED THAT THE RING COVER WAS MISSING, ONE CASE SCREW WAS MISSING, THE RING WAS MISSING, THE BATTERY DRAWER WAS BROKEN, THE KEYBOARD WAS SCRATCHED AND THERE WAS A PIECE OF FOREIGN MATERIAL IN BETWEEN THE DISPLAY AND THE DISPLAY LENS.

    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 THAT THE EXTERNAL PULSE GENERATOR (EPG) DISPLAY HAS BAD PIXELS ALL OVER, THE CASE IS BROKEN AND IT FAILED THE SELF TEST. THE EPG HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469065 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1