BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860122 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00797
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 5, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 UPPER AND LOWER CASES ARE BROKEN. BATTERY RELEASE, KNOBS, SIDE BAIL COVERS, RING COVER AND BATTERY DRAWER ARE CONTAMINATED. LEAD FLEX COVER IS CORRODED, BATTERY CONTACTS ARE COMPRESSED, AND KEYBOARD IS SCRATCHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CASE IS BROKEN. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339493 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1