BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z

    MDR report key: 2201665 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11163
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S33
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICULAR IMPEDANCE HAS DECREASED AND THE UNIPOLAR MEASUREMENT IS GREATER THAN THE BIPOLAR. IT WAS NOTED THERE WERE NON PHYSIOLOGIC INTERVALS RECORDED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    SHORT INTERVAL COUNTS (SIC) WERE ALSO OBSERVED. IT WAS LATER REPORTED THAT OCCASIONAL OVERSENSING OR NOISE HAD BEEN SEEN. AUTOMATIC AND MANUAL THRESHOLD MEASUREMENTS WERE VERY DIFFERENT AND VARIABLE. THE LEAD WAS CAPPED AND REPLACED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO, INC. 5034 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R 5534 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR