BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791095 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01692
    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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 CASE AND LOWER CASE WERE BROKEN, THE SIDE BAILS AND RING WERE ALSO MISSING. IT WAS ALSO NOTED THAT THE SIDE BAIL COVERS, RING COVER AND BATTERY DRAWER WERE BROKEN, THE HEART BLOCK WAS CONTAMINATED, THE KEYBOARD WAS SCRATCHED AND THE BATTERY CONTACTS WERE COMPRESSED.

    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. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE MANUFACTURING DATE. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE REPORTED EVENT, THE UPPER CASE AND LOWER CASE WERE BROKEN, THE SIDE BAILS AND RING WERE ALSO MISSING. IT WAS ALSO NOTED THAT THE SIDE BAIL COVERS, RING COVER AND BATTERY DRAWER WERE BROKEN, THE HEART BLOCK WAS CONTAMINATED, THE KEYBOARD WAS SCRATCHED AND THE BATTERY CONTACTS WERE COMPRESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) IS MISSING HARDWARE ON THE LOWER CASE, AND THE CASE NEEDS TO BE REPLACED. THE EPG WAS RETURNED FOR REPAIR AND CALIBRATION. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    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