BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2160604 · Received July 6, 2011

    Report

    Report Number
    1627487-2011-00917
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE PT IS EXPERIENCING OVERSTIMULATION AT THE IPG POCKET. THE REPORTED SENSATION LASTED FOR APPROX 15 SECONDS AND THEN DISSIPATED. ACCORDING TO THE PT, THE ALLEGED OVERSTIMULATION HAS OCCURRED ON AT LEAST TWO PRIOR OCCASIONS. HE DENIES ANY FALLS OR TRAUMA TO THE IPG SITE WHICH MAY HAVE CONTRIBUTED TO THIS MATTER. IN ADDITION, A DIAGNOSTIC TEST DID NOT REVEAL ANY IMPEDANCE ISSUES. F/U ON THIS MATTER FOUND THAT THE PT HAS NOT EXPERIENCED ANY SUBSEQUENT OCCURRENCES OF OVERSTIMULATION SINCE REPORTING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2772041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| SCS LEAD: MODEL: UNK