BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2812441 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02449
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    Removal / Correction Number
    Z-0111-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED. THE DEVICE WAS APPROACHING RECOMMENDED REPLACEMENT TIME AS THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS THE MINIMUM BATTERY WAS 2.887 TO 2.628 VOLTS BETWEEN (B)(4) 2012 AND (B)(4) 2012 IS BEFORE DEVICE RECOMMENDED REPLACEMENT TIME <=2.6251 VOLT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ONLY LASTED APPROXIMATELY 3.5 YEARS AND THE CUSTOMER WAS CONCERNED. FROM AVAILABLE PRINTOUTS, THE DEVICE WAS APPROACHING ELECTIVE REPLACEMENT INDICATOR. IT WAS NOTED THAT MULTIPLE HIGH VOLTAGE THERAPIES HAD BEEN DELIVERED. 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 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D234TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R