BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 2953115 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00193
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 19, 2012
    Report Date
    November 23, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    OJX
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED AN ELECTRICAL RESET. 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
    56278 CONSULTA CRT-P OJX IPG MFG SWITZERLAND C3TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention