BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2953195 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00208
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    July 11, 2012
    Report Date
    February 11, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    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. 5594 IMPLANTABLE PACING LEAD 2007 (B)(6); 4193 IMPLANTABLE PACING LEAD 2007 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PRODUCT PERFORMANCE DATA WAS RECEIVED, ANALYZED, AND HIGH RESISTANCE/INPEDANCE WAS NOTED. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2012. THE WEEKLY AND DAILY PACE LEAD TREND DATA SHOW VARIOUS SPIKE INCREASES FOR SVC DEFIBRILLATION WAS 61 TO 244 OHMS BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM WAS TRIGGERED DUE TO HIGH IMPEDANCE. A CONNECTION ISSUE WAS SUSPECTED SO THE CONNECTION WAS REVISED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM WAS TRIGGERED DUE TO HIGH IMPEDANCE. A CONNECTION ISSUE WAS SUSPECTED SO THE CONNECTION WAS REVISED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57556 MAXIMO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D284TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD