BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3242734 · Received July 23, 2013

    Report

    Report Number
    2183613-2013-00787
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR CODE WHEN AN EXTERNAL PULSE GENERATOR WAS TURNED ON FOR TESTING. IT WAS NOT ATTACHED TO A PATIENT WHEN THE ERROR OCCURRED. THE BIOMEDICAL ENGINEER WAS ABLE TO CLEAR THE ERROR BY REMOVING AND REINSERTING THE BATTERY. THE DEVICE THEN POWERED ON WITHOUT ANY ISSUE. THE ERROR HAS NOT OCCURRED AGAIN AND THE DEVICE REMAINS IN USE. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343073 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1