BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2203669 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01597
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 80% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DEVICE REACHED ELECTIVE REPLACEMENT INDICATIONS SEVENTEEN MONTHS AFTER IMPLANT. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE PATIENT HAD SUFFERED ARRHYTHMIC STORM, REQUIRING MANY SHOCK DELIVERIES. THE CRT-D DEVICE WAS REMOVED 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
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NVZ MEDTRONIC S.A. D234TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R