BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153498 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00610
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, DEVICE FAILED INCOMING FUNCTIONAL TEST, WOULD NOT POWER UP, AS A RESULT THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS REPLACED. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, BOTH BAIL COVERS WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE BATTERY DRAWER WAS BROKEN, THE KEYBOARD WAS SCRATCHED, AND THE SERIAL NUMBER LABEL WAS DAMAGED. WITH THE REPLACEMENT OF THE MAIN BOARD, ALL CORRECTIVE ACTIONS HAVE BEEN COMPLETED PER THE FIELD ACTION.

    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) FAILED THE SELF-TEST AND WOULD NOT STAY POWERED UP. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258129 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1