BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153621 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00616
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE "PULSE WIDTH WAS NOT CORRECT TO ITS SETTINGS." PULSE WIDTH IS NOT A SELECTABLE SETTING, IT IS A FIXED VALUE. THE GENERATOR WAS RECALIBRATED AND FUNCTIONALLY TESTED AND PASSED ALL FINAL QUALITY ASSURANCE TESTS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE WIDTH ON THE EXTERNAL PULSE GENERATOR WAS NOT CORRECT TO ITS SETTINGS. THE ATRIAL WIDTH WAS SHORTER THAN IT WAS SET TO AND THE VENTRICULAR WIDTH WAS LONGER THAN IT WAS SET TO. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE WIDTH ON THE EXTERNAL PULSE GENERATOR WAS NOT CORRECT TO ITS SETTINGS. THE ATRIAL WIDTH WAS SHORTER THAN IT WAS SET TO AND THE VENTRICULAR WIDTH WAS LONGER THAN IT WAS SET TO. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254374 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1