BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3993609 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01071
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 2, 2014
    Report Date
    June 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. 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 REPORTED EVENT, THE LOWER CASE WAS BROKEN. IT WAS ALSO NOTED THAT THE HIGH RATE COVER WAS MISSING, THE MAIN CLEAR COVER WAS MISSING, THE UPPER CASE WAS BROKEN, ALL THREE CONTROL KNOBS WERE BROKEN, ONE BATTERY RELEASE LATCH WAS BROKEN, ONE BAIL COVER WAS BROKEN, THE RING COVER WAS BROKEN, THREE CASE SCREWS WERE MISSING, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS CORRODED AND THE BATTERY FLEX WAS CORRODED. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR OF PHYSICAL DAMAGE AFTER THE UNIT WAS DROPPED. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468338 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1