BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III MARQUIS

    MDR report key: 2451632 · Received February 14, 2012

    Report

    Report Number
    6000094-2012-00138
    Event Type
    Injury
    Date Received
    February 14, 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). PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. BATTERY DEPLETION INDICATED/ELECTIVE REPLACEMENT INDICATOR (ERI) OCCURRED ON (B)(4) 2011, DEVICE ERI<=2.62 VOLT. WEEKLY BATTERY VOLTAGE LOG DATA SHOWS MIN BAT=2.64 TO 2.62 VOLTS MINIMUM BETWEEN (B)(4) 2011 AND (B)(4) 2011. THERE WERE TWO PATIENT ALERTS FOR LOW BATTERY VOLTAGE ON (B)(4) 2011 03:00:03 AND (B)(4) 2011 03:00:03. THE DEVICE WAS RETURNED AND ANALYZED. THE BATTERY DEPLETION WAS FOUND TO BE NORMAL AND MET 80% OF EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTIVE REPLACEMENT INDICATOR WAS TRIGGERED POSSIBLY DUE TO PREMATURE BATTERY DEPLETION. THE DEVICE WAS REMOVED 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 60 YR Hospitalization| R