BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952969 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00174
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE UNIT WOULD INTERMITTENTLY SHUT DOWN WHEN THE BATTERY WAS REMOVED. ANALYSIS ALSO FOUND THAT THE LOWER AND UPPER CASES AND RING COVER WERE BROKEN, ONE SIDE BAIL COVER AND KNOBS WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED AND THE KEYBOARD WAS IMPROPERLY INSTALLED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) DOES NOT "STAY ON" FOR THE SET 15 SECONDS WHEN REPLACING THE BATTERY. THE EPG WAS RETURNED FOR THE REPAIR OF THE BATTERY DRAWER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) DOES NOT "STAY ON" FOR THE SET 15 SECONDS WHEN REPLACING THE BATTERY. THE EPG WILL BE RETURNED FOR THE REPAIR OF THE BATTERY DRAWER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55719 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1