BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-P

    MDR report key: 2964844 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02386
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT STORING DIAGNOSTICS. FOLLOW UP WAS UNABLE TO OBTAIN FURTHER INFORMATION. THE STATUS OF THE DEVICE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67264 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1