BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS DR

    MDR report key: 1875054 · Received October 19, 2010

    Report

    Report Number
    2647346-2010-00657
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    April 2, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S23
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE LOST TELEMETRY AND FUNCTION DUE TO BATTERY DEPLETION. THERE IS NO EVIDENCE TO INDICATE THE DEPLETION WAS ANYTHING OTHER THAN NORMAL. THE DEVICE WAS FULLY FUNCTIONAL WHEN POWERED WITH AN EXTERNAL SOURCE. CURRENT DRAIN LEVELS WERE NORMAL. BASED ON RESIDUAL VOLTAGE AND IMPEDANCE THERE IS NO EVIDENCE OF A CATHODE TO ANODE SHORT ON THE BATTERY. SINCE THERE IS NO SAVE TO DISK OR OTHER SOURCES OF DEVICE DATA AVAILABLE THERE IS NO WAY TO DETERMINE IF THE DEVICE LASTED UNTIL IT'S EXPECTED LONGEVITY. THE RESULT OF ANALYSIS IS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CHECKING THE DEVICE WITH A MAGNET AND WAS UNABLE TO HEAR THE TONE. THE PATIENT WENT TO THE EMERGENCY ROOM AND THE REPRESENTATIVE WAS UNABLE TO GAIN TELEMETRY WITH THE DEVICE DESPITE MULTIPLE ATTEMPTS. THE PATIENT ALERT TONE WAS NOT HEARD WHEN THE PROGRAMMER HEAD WAS PLACED OVER THE DEVICE. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7274 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 1488T COMPETITOR IMPLANTABLE PACING LEAD| 1581 COMPETITOR IMPLANTABLE TACHY LEAD