BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 3863245 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01332
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 2, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A HOLTER MONITOR WAS BEING WORN BY THE PATIENT, THE DEVICE DID SOMETHING THAT THE "HOLTER SEES... (BUT) THAT IS HARD TO RECOGNIZE." SIGNIFICANT ANALYSIS OF DEVICE AND HOLTER EPISODES AND SESSION DATA WERE REVIEWED AND IT MAY BE THAT THE DEVICE WAS PACING AT A HIGHER RATE THAN EXPECTED BY THE PHYSICIAN. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341101 CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C3TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention