BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2812088 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16906
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE LEFT VENTRICULAR (LV) LEAD ALSO WAS FOUND TO HAVE AN ABRUPT INCREASE IN IMPEDANCE IN THE SAME TIMEFRAME AS OCCURRED ON THE RIGHT VENTRICULAR LEAD. MANUAL LV THRESHOLD REVEALED NO CAPTURE AT HIGH OUTPUT. DURING THE PROCEDURE THE LV LEAD WAS TESTED WITH THE ANALYZER AND FOUND TO BE ACCEPTABLE AND IT WAS DETERMINED THAT THE LV IMPEDANCE WAS HIGH BECAUSE THE PACING VECTOR WAS WITH THE RV COIL. IT WAS ALSO REPORTED THAT THE WARNING DID NOT APPEAR UNTIL SEVERAL MONTHS AFTER THE HIGH IMPEDANCE TRENDS OCCURRED. THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4193

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other 4574 IMPLANTABLE PACING LEAD| 6948 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB