BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2813222 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01929
    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
    OR, 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 AND LOWER CASE HALVES WERE BROKEN. IT WAS ALSO NOTED THAT THE BATTERY RELEASE, RING COVER, HEART BLOCK, HEART WIRE CONTACTS, MAIN PRINTED CIRCUIT BOARD (PCB) AND HEART LEAD FLEX WERE CONTAMINATED, BOTH BAIL COVERS, BATTERY DRAWER, AND BATTERY DRAWER O-RING WERE BROKEN, THE LEAD FLEX COVER AND BATTERY FLEX WERE CORRODED, ONE PCB FLEX WAS CREASED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE KEYBOARD WINDOW WAS SCRATCHED, THE SERIAL NUMBER LABEL WAS TORN AND THE DISPLAY WAS OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASE WAS BROKEN. 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