BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 7962266 · Received October 12, 2018

    Report

    Report Number
    2183613-2018-00208
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 4, 2018
    Report Date
    October 12, 2018
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS SUMMARY: AT ANALYSIS, IT WAS NOTED THAT THE LOWER CASE WAS BROKEN, THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN, ALL BAILS AND BAIL COVERS WERE MISSING. THE UNIT WAS SCRAPPED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WHICH WAS RETURNED FOR PREVENTIVE MAINTENANCE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTU RER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801643 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388XG

    Patients

    Seq Age Sex Outcome Treatment
    1