BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153214 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01401
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE HEART LEAD FLEX. THIS ANALYSIS COULD NOT FIND ANY DEFECTS AND COULD NOT CONFIRM THE SENSITIVITY FAILURES NOTED DURING SERVICING OF THE DEVICE.

    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. EVALUATION SUMMARY: THE GENERATOR WAS RETURNED AND ANALYSIS FOUND THE HEART LEAD FLEX TO BE OUT OF SPECIFICATION ELECTRICALLY. (B)(4).

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WAS RETURNED FOR ITS ANNUAL TEST AND CALIBRATION AND WAS FOUND TO BE OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254977 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1