BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4160847 · Received October 10, 2014

    Report

    Report Number
    2183613-2014-01181
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    May 29, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. 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 UPPER AND LOWER CASES ARE BROKEN. HIGH RATE COVER, ONE SIDE BAIL, AND THE RING ARE MISSING. BATTERY DRAWER, TWO SIDE BAIL COVERS, RING COVER, AND OUTPUT CONNECTOR ARE BROKEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CASE IS DAMAGED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND CALIBRATION, 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
    641541 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1