BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR AT

    MDR report key: 2812027 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02397
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 82% 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.

    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 THE SAME AS A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK OCCURRED ON (B)(6) 2012; DEVICE RRT <=2.62 VOLTS. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.64 TO 2.59 VOLTS BETWEEN (B)(6)2012 AND (B)(6) 2012. THERE WERE TWO PATIENT ALERTS FOR LOW BATTERY VOLTAGE ON (B)(6) 2012 AND (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE PHYSICIAN SUSPECTED PREMATURE BATTERY DEPLETION. REVIEW OF PERFORMANCE DATA INDICATED A PATIENT ALERT TRIGGERED FOR LOW BATTERY VOLTAGE. 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