BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 3991082 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14346
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-0111-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED WHETHER THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND EARLY BATTERY DEPLETION WAS SUSPECTED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD THRESHOLDS WERE HIGH AND THE DEVICE OUTPUT WAS PROGRAMMED HIGH. THE LOWER RATE LIMIT WAS ADJUSTED AND THE PATIENT NOW PACES LESS THAN ONE PERCENT OF THE TIME IN THE ATRIUM. THE DEVICE WAS EXPLANTED AND REPLACED AND THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467563 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 00048 YR Hospitalization| R 6947 LEAD, 5076 LEAD, 4195 LEAD