BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR AT

    MDR report key: 2810598 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02415
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    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) - WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION WAS INDICATED. TIME OF ELECTIVE REPLACEMENT INDICATOR IN SAVE TO DISK WAS ON (B)(6) 2012. DEVICE ELECTIVE REPLACEMENT INDICATOR WAS LESS THAN OR EQUAL TO 2.62 VOLTS. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MINIMUM BATTERY VOLTAGE EQUAL TO 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. THERE WAS ONE PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2012. (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 80% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) FASTER THAN EXPECTED. THE DEVICE LONGEVITY MEASURED FIVE DAYS BEFORE ERI TRIGGERED WAS 2.93 VOLTS. HOWEVER, THE BATTERY VOLTAGE MEASURED SIX MONTHS PRIOR TO THAT INDICATED 2.74 VOLTS. 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. C174AWK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R