BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2964404 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02300
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 8, 2012
    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
    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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2006; 6949 IMPLANTABLE TACHY LEAD (B)(6) 2006. (B)(4).

    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 BY THE PATIENT'S SPOUSE THAT THE PATIENT IS CONCERNED THAT THE BATTERY VOLTAGE ON THE PATIENT'S DEVICE IS LOW AND THAT THE PATIENT IS PACING DEPENDANT. THE PATIENT'S SPOUSE ALSO STATED THAT "THE DEVICE IS ONLY THREE YEARS OLD". ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS BEEN REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68926 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 00082 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD