BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4831591 · Received June 10, 2015

    Report

    Report Number
    2183613-2015-00500
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 20, 2015
    Report Date
    April 23, 2015
    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 FOUND THE DEVICE FAILED INCOMING FUNCTIONAL TEST DUE TO INTERMITTENT OPERATION OF THE DEVICE. ANALYSIS ALSO FOUND THE UPPER CASE AND LOWER CASE WERE BROKEN, BAIL COVER AND RING COVER WERE CONTAMINATED, AND ONE O-RING BATTERY LATCH WAS MISSING. (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
    378607 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1