BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II CRT-D

    MDR report key: 3862521 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01373
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- THE DEVICE WAS RETURNED AND ANALYZED. THE RETURNED DEVICE IDENTIFIED A FAILURE CONDITION THAT DISAPPEARED DURING ANALYSIS. RECEIVED THE DEVICE IN UNOPENED OUTER/INNER STERILE PACK.

    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 PROCEDURE THE DEVICE SHOWED A TELEMETRY PROBLEM. SPECIFICALLY NO TELEMETRY CONNECTION WITH THE DEVICE. THE PHYSICIAN MADE SEVERAL ATTEMPTS. THE DEVICE WAS NEVER IMPLANTED. A DIFFERENT DEVICE WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339488 MAXIMO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D264TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR