BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2190766 · Received July 26, 2011

    Report

    Report Number
    1627487-2011-03365
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT REC'D A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THE PT IS NOT FEELING STIMULATION AND SUSPECTED THERE WAS SOMETHING WRONG WITH THE PROGRAMMER. SHE ALLEGEDLY CLAIMED THAT IT WAS DIFFICULT TO TURN THE IPG ON AND OFF WITH THE PROGRAMMER. A REPLACEMENT PROGRAMMER WAS SENT TO THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 329073

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANTED: