BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153729 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00624
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL TESTING. IT WAS NOTED THAT THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS BROKEN, TWO SIDE BAIL COVERS WERE BROKEN, THE RING COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, ONE SIDE BAIL WAS MISSING, AND THE RING WAS BENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) PERIODICALLY "LOCKS UP" WITH BOTH THE ATRIAL AND VENTRICULAR PACING LIGHTS "SOLID GREEN" AND NO OUTPUT OR RATE GIVEN/SHOWN. THE BIOMEDICAL ENGINEER ALSO NOTED THAT DESPITE A NEW BATTERY, THE EPG WOULD SUDDENLY LOCK UP (OR AT TIMES UPON POWER UP). THE DISPLAY OF THE EPG ALSO DID NOT APPEAR TO BE AS EXPECTED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254791 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1