BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 2963548 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00444
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 30, 2006
    Report Date
    December 13, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A PROGRESSION OF DYSPNEA AND HYPERTENSION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(4) CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66681 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R