BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4831503 · Received June 10, 2015

    Report

    Report Number
    2183613-2015-00507
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    February 19, 2015
    Report Date
    March 24, 2015
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: DURING ANALYSIS THE DEVICE FAILED INCOMING VXI TESTING, THE HEART WIRE LEADS ON THE TESTER WERE CLEANED AND THE FAILURE WAS RERUN 10 TIMES AND PASSED. THE FAILURE WAS ATTRIBUTED TO DIRTY HEART WIRE LEADS ON THE TESTER ITSELF. ANALYSIS FURTHER NOTED THAT THE UPPER CASE WAS BROKEN AND DENTED, THE LOWER CASE WAS BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, THE SIDE BAIL COVERS, RING COVER, SIDE BAIL AND RING WERE MISSING AND THE KEYBOARD WAS SCRATCHED. THE DEVICE WAS TO BE SCRAPPED IN-HOUSE. (B)(4).

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WAS RETURNED AS A TRADE-IN AND 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
    377745 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1