BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 2812001 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02446
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    May 22, 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
    MI, 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 AT THE PATIENT CHECK, THEY WERE NOT SEEING ANY DIAGNOSTICS. IT WAS THEN REPORTED THAT THE PATIENT DOES NOT HAVE AN ATRIAL LEAD AND THAT IMPLANT DETECT IS STILL IN PROGRESS. HOW TO TURN OFF IMPLANT DETECT WAS EXPLAINED TO THE CALLER. 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 78 YR Required Intervention (B)(4) TISSUE VALVE| 6949 IMPLANTABLE TACHY LEAD| 5071 IMPLANTABLE PACING LEAD