BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2953067 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01893
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    August 2, 2012
    Report Date
    November 29, 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
    DC, 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: 5076, IMPLANTABLE PACING LEAD, (B)(6) 2012; 4196, IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD AND THE LEAD WAS TURNED OFF. THE LV WAS ATTEMPTED TO BE TURNED BACK ON, HOWEVER AT HIGH OUTPUT THERE WAS CAPTURE BUT ALSO PACING IN THE POCKET. CAPTURE WAS LOST WHEN THE OUTPUT WAS DECREASED, AND THE PATIENT STILL FELT THE SENSATION AND DISCOMFORT IN THE POCKET. IT WAS ALSO REPORTED THAT THE LV LEAD HAD PULLED BACK INTO THE POCKET AND THE DEVICE HAD MIGRATED MEDIAL. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57076 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D204TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R (B)(4) IMPLANTABLE TACHY LEAD