BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-P

    MDR report key: 2954504 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00475
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    October 17, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FEELS DEVICE PACING DURING THE NIGHT AND STATED THE HEART "IS NOT PUMPING AS GOOD" SINCE THE DEVICE WAS IMPLANTED. THE DEVICE REMAINS IN SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58563 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC S.A. (SMO) C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR 5076 IMPLANTABLE PACING LEAD