BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2790498 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02186
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    Removal / Correction Number
    Z-0111-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THE BATTERY VOLTAGE WAS PRE/APPROACHING ERI, WHERE THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.954 TO 2.741 VOLTS BETWEEN (B)(6) 2012 AND IS BEFORE DEVICE RRT <= 2.6251 VOLT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED EARLY DEPLETION AFTER THE PATIENT RECEIVED A NUMBER OF SHOCKS. IT WAS ALSO REPORTED THAT THE DEVICE WAS PROGRAMMED TO HIGH LEFT VENTRICULAR PACING OUTPUT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPROGRAMMED TO RIGHT VENTRICULAR (RV) PACING ONLY TO SAVE THE BATTERY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D234TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention