BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM MRI

    MDR report key: 4161245 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02309
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1440-2010
    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 DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED HIGH IMPEDANCE IN THE BATTERY. CONCOMITANT MEDICAL PRODUCTS: 5086MRI52 LEAD. (B)(4). THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLY DUE TO INCREASED BATTERY IMPEDANCE. THE DEVICE WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638033 ENRHYTHM MRI PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND EMDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5086MRI58 LEAD