BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 2790015 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02137
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    April 23, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P010015/S084
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR MONTHS POST IMPLANT, THE BATTERY LONGEVITY OF THE DEVICE WAS STILL INITIALIZING AND "ALL OTHER COUNTERS, ETC. ARE BLANK." IT WAS ALSO REPORTED THAT THE DEVICE WAS MEASURING HIGH ATRIAL LEAD IMPEDANCE, BUT THE PATIENT DOES NOT HAVE AN ATRIAL LEAD. ADDITIONALLY, IT WAS NOTED THAT IMPLANT DETECT HAD NOT BEEN PROGRAMMED OFF DURING THE IMPLANT PROCEDURE; AS IMPLANT DETECT WAS PROGRAMMED ON, THE DEVICE COULD NOT COLLECT ANY DATA. IMPLANT DETECT WAS PROGRAMMED OFF AND 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 CONSULTA CRT-P IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 4296 IMPLANTABLE PACING LEAD