BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 2811042 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-02032
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 18, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL TESTING. IT WAS NOTED THAT THE LOWER CASE WAS BROKEN, ONE BAIL COVER WAS BROKEN, ONE BAIL COVER WAS MISSING, THE BATTERY CONTACTS WERE COMPRESSED, AND ONE BAIL WAS MISSING.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WOULD NOT TURN ON. THE GENERATOR WAS RETURNED FOR SERVICE. NO INDICATION WAS GIVEN AS TO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WOULD NOT TURN ON. THE GENERATOR WAS RETURNED FOR SERVICE. NO INDICATION WAS GIVEN AS TO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other