BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153333 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01415
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    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
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE DEVICE FAILED TO POWER UP. IT WAS NOTED THAT THE MAIN PRINTED CIRCUIT BOARD (PCB) AND DISPLAY WERE CONTAMINATED. (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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) WOULD NOT TURN ON. THE BATTERY WAS CHANGED, BUT ONLY THE PACE/SENSE LED (LIGHT EMITTING DIODE) CAME ON, THEN WENT OFF. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256155 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1