BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM MRI

    MDR report key: 2952296 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00102
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 15, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S38
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT OCCURRED OUTSIDE THE US AND IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY : THE SAVE TO DISK OF THE DEVICE WAS REVIEWED. IT REVEALED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO HIGH BATTERY IMPEDANCE LOGGED ON (B)(6) 2011, PRIOR TO EXPLANT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETRUNED, ANALYZED AND REVEALED HIGH BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED RECOMMENDED REPLACEMENT TIME (RRT) WITH UNEXPECTED LONGEVITY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56482 ENRHYTHM MRI PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND EMDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R