BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITY SSIR

    MDR report key: 3864819 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01495
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 16, 2014
    Report Date
    June 18, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THAT THE DEVICE REMAINS IMPLANTED. PATIENT INFORMATION WAS RECEIVED AND INDICATED THE PATIENT IS A PEDIATRIC PATIENT. THE PATIENT NO LONGER HAS INDICATION FOR PACING. THE DEVICE WILL NOT BE REPLACED AND WILL BE EXTRACTED AT A LATER DATE. THE DEVICE WILL NOT BE RETURNED AFTER EXPLANT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT INITIAL INTERROGATION, THE DEVICE BATTERY WAS AT OR NEAR END OF LIFE (EOL AND WAS IN BACKUP MODE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCED POCKET STIMULATION. THE DEVICE REMAINS IN USE. NO OTHER INFORMATION WAS AVAILABLE AT THIS TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337862 CLARITY SSIR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND CL562U

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Hospitalization| R