BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952628 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00135
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING AN EXTERNAL PULSE GENERATOR (EPG) THE OUTPUT MEASURED LOW AND THE PULSE WIDTH MEASURED HIGH. ANOTHER EPG WAS TESTED WITH IT AND RECEIVED THE SAME RESULT. TECHNICAL SERVICES SUGGESTED USING A "DEFIB TESTER" TO VERIFY THE OUTPUT AND PULSE WIDTH. CALLER WAS TO TRY THIS. THE STATUS OF THE EPG IS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57663 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1