BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2812755 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03771
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    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 CONFIRMED THE REPORTED EVENT, THE PROGRAMMER DID NOT POWER ON. THE PRINTED CIRCUIT BOARD WAS OUT OF ELECTRICAL SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER DOES NOT POWER ON. THE POWER CORD WAS CHANGED AND ANOTHER OUTLET TRIED, BUT STILL NOTHING. POWER SWITCH SEEMED FINE. THE PROGRAMMER IS BEING RETURNED FOR REPAIR. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER DOES NOT POWER ON. THE POWER CORD WAS CHANGED AND ANOTHER OUTLET TRIED, BUT STILL NOTHING. POWER SWITCH SEEMED FINE. THE PROGRAMMER IS BEING RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAM W/TELEMETRY C PROGRAMMER DXY MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other