BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860198 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00790
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 13, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE LOWER CASE IS BROKEN AND THE SIDE BAIL COVERS, RING COVER, SIDE BAILS, AND RING BAIL ARE MISSING. ANALYSIS ALSO FOUND THE UPPER CASE IS BROKEN, LEAD FLEX COVER IS CORRODED, BATTERY CONTACTS ARE COMPRESSED, BATTERY DRAWER IS BROKEN, KEYBOARD IS CONTAMINATED, SERIAL NUMBER LABEL IS TORN, AND MAIN PCB (PRINTED CIRCUIT BOARD) AND LCD (LIQUID CRYSTAL DISPLAY) ARE CORRODED AND CONTAMINATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE HAS A DAMAGED (CRACKED) BACK CASE. IT WAS ALSO REPORTED CLIPS AND HANGARS ON THE BACK CASE ARE MISSING. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337411 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1