BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791414 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01718
    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, THE UPPER CASE AND LOWER CASE WERE CRACKED/BROKEN AND CONTAMINATED. THE OUTPUT CONNECTORS WERE BROKEN AND THE SIDE BAIL COVERS, RING COVER, SIDE BAILS AND RING WERE BROKEN AND MISSING. IT WAS FURTHER NOTED THAT THE BATTERY RELEASE, HEART BLOCK, LEAD FLEX COVER, RELEASE SPRING, BATTERY DRAWER AND BATTERY FLEX WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD WAS SCRATCHED AND THE DISPLAY GASKET WAS OBSTRUCTING THE VIEW OF THE DISPLAY.

    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 CRACKED/BROKEN AND CONTAMINATED. THE OUTPUT CONNECTORS WERE BROKEN AND THE SIDE BAIL COVERS, RING COVER, SIDE BAILS AND RING WERE BROKEN AND MISSING. IT WAS FURTHER NOTED THAT THE BATTERY RELEASE, HEART BLOCK, LEAD FLEX COVER, RELEASE SPRING, BATTERY DRAWER AND BATTERY FLEX WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD WAS SCRATCHED AND THE DISPLAY GASKET WAS OBSTRUCTING THE VIEW OF THE DISPLAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) WAS DROPPED. THE CASE IS CRACKED, AND THE ELECTRODE SLEEVES ARE BROKEN. THE HANGERS ARE ALSO MISSING. 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