BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2790831 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03312
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 16, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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 EVENT. PROGRAMMER INTERROGATED MULTIPLE DEVICES, BOTH WIRED AND WIRELESS WITH NO INTERROGATION ISSUES. PROGRAMMER PASSED FUNCTIONAL TESTS. ECG (ELECTROCARDIOGRAM) CONNECTOR IS LOOSE ON A PRINTED CIRCUIT BOARD ASSEMBLY. DISPLAY LOWERS IN CERTAIN POSITIONS. (B)(4) RF (RADIO FREQUENCY) HEAD PASSED FUNCTIONAL TESTS. IT IS NOTED THE RF HEAD CABLE IS SLIGHTLY STIFF (FIRST 18 INCHES LEAVING THE RF HEAD). RF HEAD LABEL IS MISSING COATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLINICIAN ATTEMPTED TO INTERROGATE/ESTABLISH TELEMETRY DURING FOLLOW-UP OF A PATIENT'S IMPLANTED PACEMAKER, WITHOUT SUCCESS. TROUBLESHOOTING ATTEMPTS WERE ALSO UNSUCCESSFUL. INTERROGATION WAS SUBSEQUENTLY ACHIEVED WITH A DIFFERENT PROGRAMMER. IT WAS UNCLEAR WHETHER THE PROGRAMMER OR PROGRAMMER RF (RADIO-FREQUENCY) HEAD WAS THE CAUSE OF THE ISSUE. BOTH WERE RETURNED FOR TESTING AND REPAIR. IT WAS FURTHER NOTED THAT SUBSEQUENT TO THIS EVENT, THE PROGRAMMER AND RF HEAD WERE TESTED WITH AN IMPLANTABLE DEVICE IN THE BOX AND UTILIZED WITH SEVERAL OTHER PATIENTS SUCCESSFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 5554 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| 5054 IMPLANTABLE PACING LEAD