BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791746 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03396
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 29, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE ANALYZER MEASUREMENTS DID NOT CORRESPOND TO THE PROGRAMMER MEASUREMENTS. THE LEAD SENSING MEASUREMENT BY THE ANALYZER WAS HIGHER THAN WITH THE PROGRAMMER. THE DISPOSITION OF THE ANALYZER IS UNKNOWN AT THIS TIME. THE LEAD REMAINS 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 62 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB