BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860549 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01472
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE UNIT WOULD STAY ON FOR 1 - 2 SECONDS, INDICATOR LIGHTS WOULD FLASH AND THEN IT WOULD SHUT DOWN, AND THEREFORE THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS REPLACED. ANALYSIS ALSO FOUND THAT THE UPPER CASE WAS DAMAGED, AFFECTING THE KEYBOARD FIT AND THAT THE LOWER CASE AND BOTH BAIL COVERS WERE BROKEN, THAT THE RING COVER AND BATTERY DRAWER WERE CONTAMINATED, THE PCB FLEX WAS CREASED, THE RING WAS BENT AND THE SERIAL NUMBER LABEL WAS DAMAGED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE EXTERNAL PULSE GENERATOR WAS TURNED ON, IT WOULD STAY ON FOR 1 TO 2 SECONDS, THE PACE AND SENSE INDICATOR LIGHTS WOULD FLASH AND THEN THE GENERATOR SHUT ITSELF DOWN. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342096 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1