BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2201677 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01192
    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. 2067 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R