BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 4162974 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19300
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    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
    CT, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED THAT THE LONGEVITY CALCULATION EQUALS 98%. THE BATTERY DEPLETION CURVE EQUALS 77%. PROJECTED LONGEVITY AT RECOMMENDED REPLACEMENT TIME (RRT) EQUALS 100%. CONCOMITANT PRODUCTS: 694765, LEAD, IMPLANTED (B)(6) 2010; 5076-52, LEAD, IMPLANTED (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO EARLY BATTERY DEPLETION WHICH WAS CAUSED BY A HIGH PACING THRESHOLD ON THE RIGHT ATRIAL (RA) LEAD. THE 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
    640723 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Hospitalization| R 419688 LEAD