BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2813627 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01958
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 CASES WERE BROKEN. IT WAS ALSO NOTED THAT THE HIGH RATE COVER, RING COVER, RING BAIL, ONE CASE SCREW AND CAUTION LABEL WERE MISSING, THE SIDE BAIL COVERS AND BATTERY DRAWER O-RING WERE CONTAMINATED, THE INTERCONNECT FLEX WAS CREASED AND THE MAIN PRINTED CIRCUIT BOARD WAS OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASE WAS DAMAGED. 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. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other