BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2143105 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-02854
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT WAS RECHARGING HER IPG EVERY 1-2 DAYS. THE PATIENT REPORTED THAT THE BATTERY WOULD BE FULLY CHARGED, BUT IT FELT LIKE SHE WAS LOSING STIMULATION. THE PATIENT ALSO REPORTED A HEATING SENSATION WHILE RECHARGING (REFERENCE MANUFACTURER REPORT 1627487-2011-02490). THE IPG WAS ELECTIVELY EXPLANTED AND REPLACED ON (B)(6) 2011. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2834055

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3219