BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791026 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01618
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 24, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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): ANALYSIS CONFIRMED THE REPORTED EVENT, THE HEART LEAD FLEX WAS OUT OF SPECIFICATION WITH AN ELECTRICAL OPEN TRACE. IT WAS ALSO NOTED THAT THE UPPER CASE WAS DENTED, THE LOWER CASE WAS BROKEN, THE BATTERY RELEASE, RING COVER AND HEART BLOCK WERE CONTAMINATED, THE LEAD FLEX COVER WAS CORRODED, THE BATTERY CONTACTS WERE COMPRESSED, ONE SIDE BAIL COVER AND BAIL WERE MISSING AND ONE SIDE BAIL COVER WAS BROKEN, THE RING BAIL WAS BENT, THE MAIN PRINTED CIRCUIT BOARD WAS OUT OF ELECTRICAL SPECIFICATION AND THE KEYBOARD WAS SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE TESTING THE UNIT PACING OUTPUTS ON THE EXTERNAL PULSE GENERATOR WERE FOUND TO BE INCORRECT. THE GENERATOR WAS RETURNED FOR SERVICE. 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