BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR AT

    MDR report key: 1791746 · Received August 10, 2010

    Report

    Report Number
    6000094-2010-01436
    Event Type
    Injury
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. 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. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. 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. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHARGE TIME WAS ABOVE EXPECTED VALUES. THE BATTERY VOLTAGE WAS AT RRT 2.62 VOLTS, BUT THE RRT (RECOMMENDED REPLACEMENT TIME) FLAG WAS NOT TRIGGERED. PREVIOUS EXPERIENCE ON THIS DEVICE INCLUDES LIA (LEAD INTEGRITY ALERT) SOFTWARE WAS DOWNLOADED. OVERSENSING AND NOISE WAS OBSERVED. IT WAS ALSO NOTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHARGE TIME WAS ABOVE EXPECTED VALUES. THE BATTERY VOLTAGE WAS AT RRT 2.62 VOLTS, BUT THE RRT (RECOMMENDED REPLACEMENT TIME) FLAG WAS NOT TRIGGERED. 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 CONCERTO CRT-D DR AT ASKU NIK MEDTRONIC S.A. C174AWK ASKU

    Patients

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