BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 4831597 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-10746
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 18, 2015
    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
    CA, 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. CONCOMITANT PRODUCTS: 5071-35 LEAD, IMPLANTED: (B)(6) 2013; A 5071-35 LEAD, IMPLANTED: (B)(6) 2013; A 457445 LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED DEFIBRILLATION THERAPY WHICH WAS APPROPRIATE. HOWEVER, DUE TO A LONG NID (NUMBER OF INTERVALS TO DETECT) OF 30/40, THE PATIENT EXPERIENCED A SYNCOPAL EPISODE AND FELL. THE PATIENT'S HEAD HIT THE FLOOR AND THE PATIENT RECEIVED A MINOR FACIAL BRUISE. THE NID WAS SHORTENED TO 18/24 PER PHYSICIAN'S ORDERS, THE PATIENT WAS HOSPITALIZED DUE TO THEIR CARDIAC CONDITION, AND 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
    375625 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 00057 YR Hospitalization| L| R 694758 LEAD