BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790281 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01662
    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
    MN, US
    Reporter Occupation
    OTHER

    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 THAT THE LOWER CASE WAS BROKEN AND CONTAMINATED. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN AND CONTAMINATED, THE BATTERY RELEASE, LEAD FLEX COVER, RELEASE SPRING, BATTERY DRAWER, KEYBOARD PAD AND BATTERY DRAWER O-RING WERE CONTAMINATED, THE SERIAL NUMBER LABEL WAS COSMETICALLY DAMAGED, THE RING COVER AND TWO SIDE BAIL COVERS WERE CONTAMINATED AND THE RING WAS BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASE WAS CRACKED BY THE ATRIAL CONNECTION. 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