BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3990646 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01031
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 COULD NOT CONFIRM THE REPORTED EVENT; DEVICE PASSED ALL INCOMING FUNCTIONAL TESTS. ANALYSIS FOUND THE UPPER CASE, LOWER CASE, AND BATTERY DRAWER ARE BROKEN. RING COVER, BOTH BAIL COVERS, RING, AND BOTH BAILS ARE MISSING. BATTERY CONTACTS ARE COMPRESSED AND KEYBOARD IS SCRATCHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE SHUTS DOWN INTERMITTENTLY. THE DEVICE 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
    472680 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1