BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA MRI SR

    MDR report key: 4831330 · Received June 10, 2015

    Report

    Report Number
    9614453-2015-01208
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 20, 2015
    Report Date
    April 27, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED ADVERSE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEBRILE AND THE DEVICE WAS PARTIALLY EXTRUDED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED. IT WAS NOTED THAT THE PATIENT HAD DAMAGE IN THE LEFT SHOULDER REGION PRIOR TO THE IMPLANT OF THE ICD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380512 EVERA MRI SR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND DVMB2D4

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R