BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2812593 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01923
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE ENCODER FLEX WAS NOT SEATED. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE CONTAMINATED, THE RING COVER WAS CONTAMINATED, ONE SIDE BAIL COVER WAS BROKEN, THE BATTERY RELEASE, BATTERY DRAWER AND KEYBOARD PAD WERECONTAMINATED, AND THE BATTERY CONTACTS WERE COMPRESSED.

    Additional Manufacturer Narrative · 1

    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 THE CONTROL KNOBS ON THE EXTERNAL PULSE GENERATOR WERE "INTERMITTENT" WHEN USED (RATE, OUTPUT AND SENSITIVITY). THE GENERATOR WAS TO BE RETURNED TO 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 CONTROL KNOBS ON THE EXTERNAL PULSE GENERATOR WERE "INTERMITTENT" WHEN USED (RATE, OUTPUT AND SENSITIVITY). THE GENERATOR WAS TO BE RETURNED TO 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
    1 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other