BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM MRI

    MDR report key: 2952719 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00134
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 26, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE ACTUAL LONGEVITY WAS LESS THAN 80% OF THE 99.9% LONGEVITY LIMIT. THE NO TELEMETRY CONDITION WAS THE RESULT OF A DEPLETED BATTERY. THE EXACT CAUSE OF THE DEPLETED BATTERY COULD NOT BE DETERMINED. THE BATTERY SHOWED SIGNS OF SWELLING. BATTERY ANALYSIS AND HYBRID TESTING REVEALED NO ANOMALIES.

    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    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 THE DEVICE WAS NOT ABLE TO BE INTERROGATED AUTOMATICALLY OR MANUALLY. IT WAS ALSO NOTED THAT THE DEVICE WAS PAST ITS USE-BEFORE DATE. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56739 ENRHYTHM MRI PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY IPG MFG SWITZERLAND EMDR01

    Patients

    Seq Age Sex Outcome Treatment
    1