BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-P

    MDR report key: 2812312 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02531
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 8, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P010015/S084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE PACEMAKER FEATURE OF IMPLANT DETECT WOULD NOT COMPLETE. WITH THIS FEATURE ON, REMOTE TRANSMISSIONS ARE NOT POSSIBLE. 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
    1 CONSULTA CRT-P IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other 4285 BS COMP IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD| 1188T STJ COMP IMPLANTABLE PACING LEAD