BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790564 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01669
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    June 8, 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ONE PRINTED CIRCUIT BOARD FLEX IS CREASED. BATTERY RELEASE IS CONTAMINATED. UPPER AND LOWER CASE HALVES, BOTH BAIL COVERS, AND RING COVER ARE BROKEN. LEAD FLEX COVER IS CORRODED. BOTH BAILS AND RING ARE MISSING. BATTERY DRAWER HAS TOOL MARKS. KEYBOARD WINDOW IS SCRATCHED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. 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). ONE PRINTED CIRCUIT BOARD FLEX IS CREASED. BATTERY RELEASE IS CONTAMINATED. UPPER AND LOWER CASE HALVES, BOTH BAIL COVERS, AND RING COVER ARE BROKEN. LEAD FLEX COVER IS CORRODED. BOTH BAILS AND RING ARE MISSING. BATTERY DRAWER HAS TOOL MARKS. KEYBOARD WINDOW IS SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UPPER AND LOWER CASES OF THE EPG (EXTERNAL PULSE GENERATOR) ARE SEPARATED AT THE SEAM, AND THERE ARE SMALL CRACKS ON THE LEFT SIDE. THE EPG WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO INFORMATION WAS RECEIVED INDICATING 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