BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952191 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00088
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE BATTERY GETS HOT, THE MAIN PRINTED CIRCUIT BOARD WAS CORRODED. IT WAS NOTED THAT THE GENERATOR WAS BEING RETURNED TO THE CUSTOMER UNREPAIRED DUE TO THE AMOUNT OF DAMAGE IT HAD SUSTAINED. ANALYSIS ALSO FOUND THAT THE LOWER CASE WAS BROKEN AND THE UPPER CASE DENTED, ONE BAIL COVER WAS BROKEN AND ONE WAS MISSING, THE RING COVER WAS BROKEN, ONE BAIL WAS MISSING, THE BATTERY DRAWER WAS CONTAMINATED, THE KEYBOARD WAS SCRATCHED, THE LIQUID CRYSTAL DISPLAY (LCD) WAS CORRODED AS WAS THE HEART LEAD FLEX. (B)(4).

    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)(6). (B)(4).

    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)(6). (B)(4).

    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)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR AND ITS BATTERY GOT HOT. IT WAS CONJECTURED THAT THERE COULD BE A SHORT SOMEWHERE IN THE GENERATOR. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR AND ITS BATTERY GOT HOT. IT WAS CONJECTURED THAT THERE COULD BE A SHORT SOMEWHERE IN THE GENERATOR. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57531 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1