BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4831617 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01615
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 30, 2015
    Report Date
    April 22, 2015
    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. PRODUCT EVENT SUMMARY: DURING ANALYSIS THE DEVICE FAILED AN INCOMING VXI TEST DUE TO INTERMITTENT OPERATION. ANALYSIS ALSO NOTED THAT THE UPPER CASE WAS DENTED, BROKEN AND CONTAMINATED, THE LOWER CASE AND BATTERY DRAWER WERE BROKEN AND CONTAMINATED, THE HEARTWIRE BLOCK WAS CONTAMINATED AND THE SERIAL NUMBER LABEL WAS TORN. 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
    377315 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1