BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152148 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00519
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS MISSING PIXELS, SO THE DISPLAY WAS REPLACED. ANALYSIS ALSO FOUND THAT ONE SIDE BAIL COVER WAS MISSING AND ONE WAS CONTAMINATED, THE RING COVER WAS BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, ONE SIDE BAIL AND ONE RING BAIL WERE MISSING, THE KEYBOARD WAS SCRATCHED AND THE BATTERY RELEASE AND BATTERY DRAWER WERE CONTAMINATED. (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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LOWER LIQUID CRYSTAL DISPLAY (LCD) OF THE EXTERNAL PULSE GENERATOR (EPG) WAS MISSING SEGMENTS. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LOWER LIQUID CRYSTAL DISPLAY (LCD) OF THE EXTERNAL PULSE GENERATOR (EPG) WAS MISSING SEGMENTS. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252244 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1