BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3992874 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01093
    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. PRODUCT EVENT SUMMARY: ANALYSIS DETERMINED THAT THE HIGH RATE COVER, UPPER CASE AND ONE BAIL COVER WERE BROKEN, THAT THE BATTERY DRAWER AND ITS O-RING WERE DAMAGED, THAT THE MAIN CLEAR COVER, ONE CONTROL KNOB AND ONE KNOB SPRING WERE MISSING, THAT THE LOWER CASE WAS CONTAMINATED AND THAT THE BATTERY CONTACTS AND THE BATTERY FLEX WERE CORRODED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WAS RETURNED BECAUSE IT HAD BEEN DROPPED AND IT SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468691 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1