BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYNC III MARQUIS

    MDR report key: 2954690 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00492
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE OF THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: DATA FROM THE DEVICE WAS RECEIVED AND ANALYZED; THE DEVICE WAS ALSO RETURNED AND ANALYZED. ANALYSIS OF THE PERFORMANCE DATA SHOWED THE DEVICE REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) ON 2012 (B)(4). THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWED THE BATTERY VOLTAGE WENT FROM 2.64 VOLTS TO 2.62 VOLTS BETWEEN 2012 (B)(4) AND 2012 (B)(4). ADDITIONALLY, A LOW BATTERY VOLTAGE ALERT OCCURRED ON 2012 (B)(4). ANALYSIS OF THE DEVICE DID NOT REVEAL ANY PERFORMANCE ISSUES, BUT THE CALCULATED LONGEVITY RESULT OF 99% IS LESS THAN THE PREDICTED VALUE BASED ON THE AVAILABLE PROGRAMMED PARAMETERS. IN THE ABSENCE OF THE COMPLETE PROGRAMMING HISTORY, IT IS NOT POSSIBLE TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. THE ANALYST COMMENTED THAT THERE WAS GROMMET DAMAGE (CAUSE UNKNOWN).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE CHANGE-OUT PROCEDURE, THE PHYSICIAN WAS UNABLE TO DISCONNECT THE DEVICE SET SCREW FROM THE SU PERIOR VENA CAVA (SVC) COIL OF THE RIGHT VENTRICULAR (RV) LEAD. A DIFFERENT DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59313 INSYNC III MARQUIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND 7279

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN IMPLANTABLE DEFIB LEAD