BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 3277998 · Received August 10, 2013

    Report

    Report Number
    2182208-2013-02207
    Event Type
    Injury
    Date Received
    August 10, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. AN EMAIL WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF YET. REFERENCED ARTICLE: SAFETY OF REPETITIVE NERVE STIMULATION IN PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES. MUSCLE NERVE. JUNE 1 2013;47(6):840-844. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT UNDERWENT A REPETITIVE NERVE STIMULATION (RNS) PROCEDURE. THE ICD DETECTED THE ELECTROMAGNETIC INTERFERENCE (EMI), BUT THERE WERE NO SIGNIFICANT CHANGES AND IT WAS NOT INTERPRETED AS "INTRACARDIAC" IN NATURE. THE ICD WAS INTERROGATED AFTER THE PROCEDURE AND THERE WERE NO ADVERSE EVENTS. THE ICD 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
    383290 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC, INC. D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R