BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790951 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01590
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 9, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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, THE KEYBOARD PAD FLEX WAS CONTAMINATED, THE DISPLAY AT THE KEYBOARD PAD CONNECTOR CONNECTION WAS CONTAMINATED AND CORRODED. IT WAS ALSO NOTED THAT THE BATTERY FLEX WAS CONTAMINATED AND CORRODED, THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS CONTAMINATED, THE BATTERY RELEASE, LEAD FLEX COVER, ONE BOARD CONNECTOR CABLE, BATTERY CONTACTS, BATTERY DRAWER, AND MAIN PRINTED CIRCUIT BOARD WERE CONTAMINATED, THE RING COVER WAS BROKEN AND THE RING WAS BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WOULD GO INTO EMERGENCY MODE ON ITS OWN. IT WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WERE NO PATIENT COMPLICATIONS 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