BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM MRI

    MDR report key: 3990236 · Received August 7, 2014

    Report

    Report Number
    9614453-2014-01807
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    February 21, 2014
    Report Date
    June 23, 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
    NL
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION.  BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED HIGH IMPEDANCE IN THE BATTERY. 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 DEVICE HAD REACHED BATTERY DEPLETION IN LESS THAN THE EXPECTED 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
    464214 ENRHYTHM MRI PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND EMDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R