BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2953718 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00191
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 22, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC MILACA, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: 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 (B)(4):THE EXTERNAL PULSE GENERATOR WAS RETURNED FOR ITS ANNUAL TEST AND CALIBRATION AND ANALYSIS FOUND THAT THE LOWER CASE WAS BROKEN, SOIT WAS REPLACED, THE BATTERY CONTACTS WERE COMPRESSED, SO THEY WERE REPLACED, THE BATTERY DRAWER WAS OUT OF SPECIFICATION AND IT WAS REPLACED, AND THE ELECTRICAL AND MECHANICAL PARTS WERE INSPECTED AND THE 9-VOLT BATTERY WAS REPLACED. THE UNIT WAS RE-CALIBRATED AND FUNCTIONALLY TESTED, AND IT PASSED ITS FINAL QUALITY ASSURANCE TESTS. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57288 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC 5388

    Patients

    Seq Age Sex Outcome Treatment
    1