BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4163160 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-03007
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC, 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, RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE DEVICE FAILED INCOMING FUNCTIONAL TESTING, FUNCTIONAL TEST FAILURES RERAN TEN TIMES AND THE DEVICE PASSED (INTERMITTENT OPERATION). ANALYSIS ALSO FOUND UPPER CASE, LOWER CASE, AND ONE SIDE BAIL COVER ARE BROKEN AND CONTAMINATED. (B)(4).

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644887 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1