BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791277 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01705
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 5, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. DEVICE POWERED UP AND LOCKED UP. VOLTAGE OF BATTERY RETURNED WITH DEVICE WAS FOUND LOW. MAIN PRINTED CIRCUIT BOARD WAS ALSO FOUND OUT OF ELECTRICAL SPECIFICATION (BATTERY REMOVAL AMPLITUDE) WHICH IS NOT RELATED TO THE REPORTED EVENT. UPPER AND LOWER CASES, SIDE BAIL COVERS, RING COVER, AND BATTERY DRAWER ARE BROKEN. BATTERY RELEASE, HEART BLOCK, AND LEAD FLEX COVER ARE CONTAMINATED. THREE WRONG CASE SCREWS WERE USED. BATTERY CONTACTS ARE COMPRESSED. SIDE BAILS AND RING ARE MISSING. LCD (LIQUID CRYSTAL DISPLAY) GASKETS STICK OUT INTO THE DISPLAY AREA. KEYBOARD IS SCRATCHED (COSMETIC).

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) IS STUCK IN THE LOCK MODE. THE EPG WAS RETURNED FOR REPAIR. 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