BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 2953269 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00219
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 12, 2007
    Report Date
    December 19, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    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. 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. CONCOMITANT MEDICAL PRODUCTS: 6947 IMPLANTABLE TACHY LEAD. (B)(4). LEAD REMAINS IN USE.

    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 THERE WAS INTERMITTENT ATRIAL NON-CAPTURE. THE DEVICE ATRIAL OUTPUT WAS PROGRAMMED HIGHER, AND THE DEVICE AND ATRIAL LEAD REMAIN 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
    56110 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention 5554 IMPLANTABLE PACING LEAD