BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152406 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00675
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS "BLEEDING" AND IT WAS THEREFORE REPLACED. ANALYSIS ALSO FOUND THE UPPER AND LOWER CASES, BOTH BAIL COVERS AND THE BATTERY DRAWER WERE BROKEN, THAT THE RING COVER WAS CONTAMINATED, THE BATTERY CONTACTS COMPRESSED, THE RING WAS MISSING AND THE KEYBOARD WAS SCRATCHED.

    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 LIQUID CRYSTAL DISPLAY (LCD) OF THE EXTERNAL PULSE GENERATOR HAD BLACKED OUT SEGMENTS ON THE TOP PORTION. 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 LIQUID CRYSTAL DISPLAY (LCD) OF THE EXTERNAL PULSE GENERATOR HAD BLACKED OUT SEGMENTS ON THE TOP PORTION. 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
    252809 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1