BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 4162656 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02511
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 8, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-0111-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS DEVICE WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. PRODUCT: 4054 LEAD 2009 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT HAS BEEN HEARING INTERMITTENT TONES FROM THE DEVICE FOR ABOUT A WEEK AND PRESENTED TO THE EMERGENCY ROOM (ER). THE PATIENT HAS ALSO BEEN EXPERIENCING FATIGUE, WEAKNESS, DIFFICULTY BREATHING AND TINGLING IN THE ARMS, BUT ALSO STATED THE ISSUES STARTED AFTER BEGINNING TO WORK OUT AT THE GYM. FOLLOW-UP WITH THE DEVICE CLINIC WAS ATTEMPTED HOWEVER THE PATIENT HAD NOT CONTACTED THE PHYSICIAN AND NO ADDITIONAL INFORMATION COULD BE OBTAINED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643129 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR 6947-65 LEAD, 5071-53 LEAD