BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS VR

    MDR report key: 2200653 · Received August 11, 2011

    Report

    Report Number
    2647346-2011-01001
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    March 1, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S29
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): UPON PRELIMINARY ANALYSIS, THE DEVICE HAD NO TELEMETRY AND NO PACING OUTPUT. THE DEVICE LOST TELEMETRY AND FUNCTION DUE TO BATTERY DEPLETION WHICH WAS REACHED ON (B)(6) 2011. THE CAUSE OF THE DEPLETION CANNOT BE DETERMINED. THE RESIDUAL VOLTAGE AND IMPEDANCE INDICATES THAT THE BATTERY WAS NOT INTERNALLY SHORTED. SINCE NO PERFORMANCE DATA COULD BE RETRIEVED FROM THE DEVICE AND NO OTHER DATA WAS PROVIDED FROM THE FIELD THERE IS NO WAY TO CONFIRM THIS RESULT. UPON VISUAL EXAMINATION OF THE DEVICE, IT WAS NOTICED THAT PART OF THE CIRCUIT WAS DAMAGED WHEN DEVICE WAS OPENED. ANALYSIS WAS CEASED AT THIS POINT. THE RESULT OF ANALYSIS IS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INDICATED ELECTIVE REPLACEMENT (ERI) AND THEN WENT FROM ERI TO END OF LIFE (EOL) IN LESS THAN ONE MONTH. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7230CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD