BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 3991700 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01679
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 12, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE 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

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE 7304 DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WENT TO EARLY ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER 3 AND A HALF YEARS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD DAMAGE AND HIGH THRESHOLDS. REVIEW OF PERFORMANCE DATA REVEALED THAT THERE WAS NO PATIENT ALERT AND THE PACING LEAD IMPEDANCE INCREASED SLOWLY. THE DEVICE WAS EXPLANTED AND REPLACED. THE RV LEAD 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
    472753 INSYNC MAXIMO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND 7304

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 6949 LEAD