BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790802 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01680
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE REPORTED EVENT, THE UPPER AND LOWER CASE HALVES WERE BROKEN. IT WAS ALSO NOTED THAT THE BATTERY RELEASE AND BATTERY DRAWER WERE CONTAMINATED, BOTH BAIL COVERS AND RING COVER WERE BROKEN, THE LEAD FLEX COVER WAS BROKEN AND CORRODED, ONE PRINTED CIRCUIT BOARD FLEX WAS CREASED, THE BATTERY CONTACTS WERE COMPRESSED, BOTH BAILS, BATTERY DRAWER O-RING AND RING WERE MISSING, THE SERIAL NUMBER LABEL WAS TORN AND THE OUTPUT FLEX AND BOTH OUTPUT CONNECTOR LATCHES WERE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD PHYSICAL DAMAGE, A CASE WAS BROKEN AND THERE WAS A HOLE IN THE UNIT. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF 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