BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-P

    MDR report key: 2954730 · Received February 11, 2013

    Report

    Report Number
    2182208-2013-00457
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ATRIAL FIBRILLATION ABLATION. THE PATIENT WAS CARDIOVERTED AND A FEW BEATS OF NON CAPTURE ON THE RIGHT AND LEFT VENTRICLE WERE NOTED. THE DEVICE WAS CHECKED AND WAS FUNCTIONING NORMALLY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58821 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ RICE CREEK MFG C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1