BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2812771 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03772
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 25, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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): THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM SLEEVE HEAD AND ON THE HELIX MECHANISM ITSELF, AND THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE RIGHT VENTRICULAR LEAD IMPEDANCE WAS LOW WHEN MEASURED THROUGH THE ANALYZER. MULTIPLE POSITIONS WERE CHECKED AND A DIFFERENT ANALYZER CABLE WAS USED, HOWEVER THE IMPEDANCE REMAINED LOW. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. IT WAS NOTED THAT THE ANALYZER ALSO MEASURED THE REPLACEMENT LEAD IMPEDANCE LOW, BUT WHEN THE LEAD WAS CONNECTED TO THE DEVICE, THE IMPEDANCE WAS WITHIN NORMAL LIMITS. SUBSEQUENT TO THIS IMPLANT PROCEDURE, THE ANALYZER HAD NO FURTHER ISSUES AND IT IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PACING SYSTEM ANALYZER DXY MEDTRONIC, INC. 2290

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other