BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2201678 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01193
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY: (B)(4): ANALYSIS COULD NOT CONFIRM THE REPORTED TELEMETRY ISSUES. A CIRCUIT BOARD WAS FOUND TO BE OUT OF SPECIFICATION. IT WAS ALSO OBSERVED THAT THE POWER CORD BAY LATCH WAS BROKEN OFF. (B)(4): ANALYSIS FOUND THAT THE PROGRAMMER RF HEAD PASSED ALL TESTING. IT WAS NOTED THERE WAS RUPTURED INSULATION ON THE CABLE, WITH EXPOSED WIRE. (B)(4): NO ANOMALIES WERE FOUND. THE PROGRAMMER RF HEAD PASSED ALL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY WAS EITHER POOR OR NONE FOR ANY DEVICE. THE PROGRAMMER RF HEAD WAS REPLACED, WITH THE SAME PROBLEM. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANOTHER PROGRAMMER WAS USED, WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER RF HEAD KRG MEDTRONIC, INC. 2067L ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R