BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2812709 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01925
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 24, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    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 CONTROL KNOB, WASHER, NUT, TWO SIDE BAIL COVERS, TWO CASE SCREWS AND TWO SIDE BAILS WERE MISSING. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN/CONTAMINATED, THE BATTERY RELEASE, LEAD FLEX COVER, AND DISPLAY WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE BATTERY DRAWER WAS BROKEN AND CONTAMINATED, THE KEYBOARD PAD WAS COSMETICALLY DAMAGED, AND THE ENCODER FLEX WAS OUT OF SPECIFICATION.

    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

    THE RETURN PAPERWORK INDICATED THAT THE NUT AND WASHER FOR THE SENSE POTENTIOMETER ON THE EXTERNAL PULSE GENERATOR (EPG) WERE MISSING AND THAT IT WAS "BROKEN." IT WAS FURTHER NOTED THAT THE EPG HAD "MISSING HARDWARE." THE EPG 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 BY THE BIOMEDICAL ENGINEER THAT THE NUT AND WASHER FOR THE "SENSE POT" ON THE EXTERNAL PULSE GENERATOR WERE MISSING. BECAUSE THESE ARE NOT PARTS THAT CAN BE SENT OUT TO THE ACCOUNT, IT WAS INDICATED THAT THE GENERATOR WOULD NEED TO BE RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT THE NUT AND WASHER FOR THE "SENSE POT" ON THE EXTERNAL PULSE GENERATOR WERE MISSING. BECAUSE THESE ARE NOT PARTS THAT CAN BE SENT OUT TO THE ACCOUNT, IT WAS INDICATED THAT THE GENERATOR WOULD NEED TO BE RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other