BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 2203835 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04440
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 1, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S171
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED DUE TO EPISODES OF VENTRICULAR TACHYCARDIA (V-TACH.) AT THE TIME, THE CARDIOLOGIST WAS UNABLE TO CHECK THE DEVICE WITH THE PROGRAMMER SINCE THEY "DID NOT HAVE THE SOFTWARE." A FIELD REP WAS CONTACTED, AND WAS ABLE TO INTERROGATE THE DEVICE. THE DEVICE WAS THEN REPROGRAMMED, AND THE REP PROCEEDED TO UPDATE THE SOFTWARE ON THE CARDIOLOGIST'S PROGRAMMERS. THE PATIENT WAS NOT SATISFIED WITH THE TIME IT TOOK FOR THE FIELD REP TO REACH THE HOSPITAL, AND REPORTED "COULD HAVE DIED IN THAT AMOUNT OF TIME." IT WAS FURTHER REPORTED THAT THE PATIENT IS REQUESTING ASSURANCE THAT SERVICES WILL BE AVAILABLE WHILE TRAVELING AND IS "NOT VERY COMFORTABLE" WITH HAVING THE DEVICE IMPLANTED IF SERVICES CANNOT BE GUARANTEED AND DELIVERED IN A TIMELY MANNER WHEN TRAVELING. THE DEVICE 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
    1 PROTECTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D334TRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD