BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 1013553 · Received March 10, 2008

    Report

    Report Number
    2647346-2008-00080
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    April 24, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS AFTER BEING EXPLANTED DUE TO VARYING ATRIAL LEAD IMPEDANCE READINGS, SOME AS HIGH AS 10,000 OHMS. DURING DEVICE EXPLANT, THE PHYSICIAN PLUGGED THE VENTRICULAR LEAD INTO THE ATRIAL PORT AND WAS ABLE TO REPRODUCE THE VARIABLE IMPEDANCE READINGS. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS AFTER BEING EXPLANTED DUE TO VARYING ATRIAL LEAD IMPEDANCE READINGS, SOME AS HIGH AS 10,000 OHMS. DURING DEVICE EXPLANT, THE PHYSICIAN PLUGGED THE VENTRICULAR LEAD INTO THE ATRIAL PORT AND WAS ABLE TO REPRODUCE THE VARIABLE IMPEDANCE READINGS. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other 4076 IMPLANTABLE PACING LEAD