BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 6933451 · Received October 9, 2017

    Report

    Report Number
    2182208-2017-01783
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    January 1, 2017
    Report Date
    August 25, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE:INAPPROPRIATE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR THERAPY DURING SURGERY: AN IMPORTANT AND PREVENTABLE COMPLICATION. JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA. 2017; 31(3):1037-1041.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING INAPPROPRIATE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) THERAPY DURING SURGERY. THE AUTHOR REPORTS THAT PATIENT PRESENTED TO THE HOSPITAL WITH SUSPECTED INFECTION AT THE IMPLANT SITE. SOON AFTER THE SURGICAL INCISION, AN INAPPROPRIATE SHOCK CAUSED APPARENT PATIENT MOVEMENT. THE SURGICAL CARE TEAM THEN REPROGRAMMED THE ICD TO DISABLE HIGH ENERGY THERAPY DURING THE PROCEDURE. IT WAS NOTED THAT THE STORED SHOCK ELECTROGRAM SHOWED A VENTRICULAR FIBRILLATION (VF) EVENT AT THE SIXTH SHORT BURST OF EMI. AT THE CONCLUSION OF THE PROCEDURE, ICD HIGH-ENERGY THERAPY WAS RESTORED. THE ICD REMAINS IN USE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709350 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC, INC. D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R