BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS VR

    MDR report key: 2531663 · Received April 12, 2012

    Report

    Report Number
    6000094-2012-00818
    Event Type
    Injury
    Date Received
    April 12, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S29
    Adverse Event
    Yes
    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. (B)(4) - PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND REVEALED THAT BATTERY DEPLETION INDICATED EARLY REPLACEMENT INDICATOR (ERI). THE TIME OF ERI IN SAVE TO DISK WAS ON (B)(6) 2012 DEVICE ERI<=2.62 VOLT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN B(V)=2.64 TO 2.62 VOLTS MINIMUM BETWEEN (B)(6) 2011 AND (B)(6) 2012. NOTED PATIENT ALERTS FOR LOW BV ON (B)(6) 2012 03:00:03 AND (B)(6) 2012 03:00:05. THE DEVICE WAS RETURNED, ANALYZED AND THERE WAS STANDARD TANTALUM CAP - LEAKAGE-UNSPECIFIED.

    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. EVALUATION SUMMARY FOR: (B)(4) - PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND REVEALED THAT BATTERY DEPLETION INDICATED/EARLY REPLACEMENT INDICATOR (ERI). THE TIME OF ERI IN SAVE TO DISK WAS ON (B)(4) 2012 DEVICE ERI<=2.62 VOLT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN B(V)=2.64 TO 2.62 VOLTS MINIMUM BETWEEN (B)(4) 2011 AND (B)(4) 2012. NOTED PATIENT ALERTS FOR LOW BV ON (B)(4) 2012 03:00:03 AND (B)(4) 2012 03:00:05.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTIVE REPLACEMENT INDICATOR AND DID NOT MEET EXPECTATIONS FOR LONGEVITY. 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 S.A. 7230CX

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R