BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III PROTECT

    MDR report key: 2812444 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02534
    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 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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE TIME OF ELECTIVE REPLACEMENT INDICATOR (ERI) IN SAVE TO DISK ON (B)(6) 2012, DEVICE ERI WAS LESS THAN OR EQUAL TO 2.62 VOLT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS A MINIMUM BATTERY VOLTAGE OF 2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. THERE WAS A PATIENT ALERT FOR LOW BATTERY VOLTAGE ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY AFTER ONLY TWO YEARS OF USE. IT WAS ALSO NOTED THAT THE DEVICE WAS IMPLANTED AFTER THE "USE BEFORE DATE." A DEVICE REPLACEMENT IS BEING PLANNED, BUT THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III PROTECT IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7285

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R