BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM MRI

    MDR report key: 2864918 · Received December 10, 2012

    Report

    Report Number
    9614453-2012-00248
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALIZED. ANALYSIS OF THE STD (SAVE TO DISK) REVEALED HIGH BATTERY IMPEDANCE. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THAT DATA INDICATES THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2012 DUE TO HIGH BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. THE DEVICE IS NOTED TO HAVE REACHED BATTERY DEPLETION EARLY DUE TO INCREASED BATTERY IMPEDANCE. THE DEVICE 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
    1 ENRHYTHM MRI PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND EMDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R