BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2120962 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-01634
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT WAS RECEIVING INEFFECTIVE STIMULATION COVERAGE. SHE ALSO STATED THAT ONE OF HER PROGRAMS CAUSES PAIN IN HER LEGS AND TIGHTNESS IN HER SHINS. FOLLOW UP ON THE PATIENT FOUND THAT SHE HAS BEEN REPROGRAMMED ON NUMEROUS OCCASIONS, BUT THESE ISSUES STILL PERSIST. NO FURTHER 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 3190298

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention IMPLANT:| IMPLANT:| SCS LEAD ACCESSORY: MODEL 1194| SCS LEAD: MODEL 3186