BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3862441 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01690
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 21, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: INITIAL ANALYSIS COULD NOT CONFIRM THAT THE DEVICE NEEDED FIELD ACTION UPDATES. HOWEVER IT WAS NOTED THAT THE CLEAR COVER WAS CONTAMINATED, THE DISPLAY WAS OUT OF ELECTRICAL SPECIFICATION AND THE SERIAL NUMBER LABEL WAS DAMAGED. FURTHER ANALYSIS WAS PERFORMED ON THE DISPLAY MODULE. VISUAL INSPECTION FOUND NO ANOMALIES. BENCH ANALYSIS FOUND CURRENT DRAIN FAILURE WHEN THE DEVICE WAS TURNED ON, WHEN A DIODE COMPONENT WAS REPLACED, CURRENT DRAIN TESTING PASSED. CONCLUSION: CONFIRMED THE FUNCTIONAL TEST FAILURES CAUSED BY A DIODE COMPONENT FAILURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A FIELD ACTION DEVICE WAS RETURNED FOR REPAIR. TECHNICAL SUPPORT (TS) HAD VERIFIED THAT THE DEVICE HAD NOT BEEN SENT IN PER THE FIELD ACTION. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338196 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1