BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2813496 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01947
    Event Type
    Malfunction
    Date Received
    October 31, 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, THE ATRIAL OUTPUT CONNECTOR WAS BROKEN AND THE UPPER AND LOWER CASES WERE BROKEN. IT WAS ALSO NOTED THAT THE BATTERY RELEASE AND LEAD FLEX COVER WERE CONTAMINATED, THE SIDE BAIL COVERS WERE BROKEN, THE RING BAIL COVER AND RING BAIL WERE MISSING, THE BATTERY CONTACTS WERE COMPRESSED AND DISCOLORED, THE KEYBOARD WAS SCRATCHED, THE SERIAL NUMBER LABEL WAS TORN, THE DISPLAY WAS OUT OF SPECIFICATION WITH THE GASKET SHOWING AND THE BATTERY DRAWER O-RING WAS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) WAS DROPPED. THE ATRIAL CONNECTOR WAS BROKEN, AND THE CASE WAS CRACKED. THE EPG WAS RETURNED FOR REPAIR. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    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