BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2953732 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00264
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 14, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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). PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE-TO-DISK OCCURRED ON (B)(4) 2012; DEVICE RRT<(><<)>=2.6251 VOLTS. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.629 TO 2.602 VOLTS BETWEEN (B)(4) 2012. THERE WERE TWO LOW BATTERY VOLTAGE ALERTS (B)(4) 2012.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DEPLETED WITHIN THREE YEARS. 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
    56504 MAXIMO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D284TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R