BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 3050966 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05919
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 2, 2012
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4). CONCOMITANT PRODUCTS: SP01 COMPETITOR IMPLANTABLE TACHY LEAD; 4194 IMPLANTABLE PACING LEAD (B)(6) 2005.

    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 THE PATIENT HAD SYNCOPE THAT WAS PRESUMED RELATED TO THE PROGRAMMED VENTRICULAR TACHYCARDIA (VT) DETECTION/TERMINATION ALGORITHM. THE PATIENT PASSED OUT, RECEIVED A SUCCESSFUL SHOCK AFTER FOUR UNSUCCESSFUL ANTI-TACHYCARDIA PACING (ATP) ATTEMPTS. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A VT STORM AND HAD RECURRENT VT PRESUMED RELATED TO THE PROGRAMMED VT DETECTION/TERMINATION ALGORITHM. THERE WERE MULTIPLE SHOCKS FOR THE VT. PRIOR TO THE SHOCK, THE PATIENT NOTED CHEST TIGHTNESS FOR 'UP TO 30 SECONDS.' IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN ADMITTED ON (B)(6) 2012 FOR MULTIPLE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCKS DUE TO VT. THE PATIENT WAS SHOCKED AT LEAST FOUR TIMES AFTER BEING STARTED ON AN AMIODARONE DRIP; THE PATIENT WAS STARTED ON A LIDOCAINE DRIP AND INCREASED METOPROLOL AS WELL. 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
    151848 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD