BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2134014 · Received June 20, 2011

    Report

    Report Number
    6000094-2011-01045
    Event Type
    Injury
    Date Received
    June 20, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    OJX
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY FOR (B)(4): ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. DEVICE WENT THROUGH PRELIMINARY AND FUNCTIONAL TEST WITH NO PROBLEM AND VERIFIED BATTERY DEPLETION. DEVICE WAS MILLED OPEN AND DURING FINAL ANALYSIS IT WAS NOTED THAT THE DEVICE LOST TELEMETRY. IT WAS NOTED THAT THE DEVICE PERHAPS HAD POWER ON RESET (POR) AND DEFAULTED TO A PACING RATE OF VVI 65 WITH AN AMPLITUDE OF 6.0 V AND A PULSE WIDTH OF 1.5 MS. UNDER THESE CONDITIONS, BOTH LOADED AND UNLOADED PACING CURRENT DRAIN LEVELS WERE NORMAL FOR THIS DEVICE. THERE IS NO EVIDENCE TO INDICATE A PROBLEM WITH THE BATTERY. WITHOUT KNOWING THE PROGRAMMING HISTORY OF THIS DEVICE THERE IS NO WAY TO DETERMINE WHY IT DID NOT MEET ITS EXPECTED LONGEVITY CALCULATION. ANALYSIS WAS COMPLETED AND DETERMINED THAT THE DEVICE LOST TELEMETRY DUE TO DAMAGE FROM BEING MILLED OPEN.

    Description of Event or Problem · 1

    T WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATIONS PREMATURELY. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 OJX MEDTRONIC S.A. D234TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB