BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790974 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01686
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    June 28, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. EVALUATION SUMMARY (B)(4): THE EXTERNAL PULSE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE RATE WAS UNABLE TO BE ADJUSTED, THE LIQUID CRYSTAL DISPLAY (LCD) BOARD CONNECTOR FOR THE ENCODER FLEX WAS NOT SEATED. ANALYSIS ALSO FOUND THAT THE UPPER AND LOWER CASES, TWO SIDE BAIL COVERS AND THE BATTERY DRAWER WERE BROKEN, THAT THE RING COVER, BATTERY RELEASE, HEART WIRE BLOCK, HEART CONTACTS AND BATTERY DRAWER WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE KEYBOARD PAD HAD COSMETIC DAMAGE AND THE ENCODER FLEX WAS OUT OF SPECIFICATION, THE FLEX WAS CRIMPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATE ON THE EXTERNAL PULSE GENERATOR WAS UNABLE TO BE ADJUSTED. THE GENERATOR WAS 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 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other