BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III MARQUIS

    MDR report key: 2811820 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02471
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S018
    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. EVALUATION SUMMARY: (B)(4) WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TIME OF ERI IN SAVE TO DISK OCCURRED ON (B)(6) 2012, WITH DEVICE ERI AT <=2.62 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN B(V) =2.64 TO 2.62 VOLTS BETWEEN (B)(6) 2012. TWO PATIENT ALERTS FOR LOW BV OCCURRED ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 94% 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 MAY HAVE REACHED THE ELECTIVE REPLACEMENT INDICATOR [ERI] PREMATURELY. 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 INSYNC III MARQUIS IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7279

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD