BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 3740575 · Received April 10, 2014

    Report

    Report Number
    3004209178-2014-06159
    Event Type
    Injury
    Date Received
    April 10, 2014
    Report Date
    January 7, 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
    NY, 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 A FIELD ACTION, BUT PRODUCT ANALYSIS FOUND THAT THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT PRODUCTS: 693558 IMPLANTABLE TACHY LEAD, (B)(6) 2010; 5076-45 IMPLANTABLE PACING LEAD, (B)(6) 2010; 419688 IMPLANTABLE PACING LEAD, (B)(6) 2010. (B)(4). EVALUATION SUMMARY: UPON ANALYSIS, NORMAL BATTERY DEPLETION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY - DEFIBRILLATOR (CRT-D) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARL IER THAN EXPECTED BY THE CUSTOMER. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216895 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 00065 YR Hospitalization| R 305C25 TISSUE VALVE