BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2003985 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-01170
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    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 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

    DEVICE 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01171. THE PT REC'D HER SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2010. IT WAS REPORTED THAT THE PT FELT OVERSTIMULATION FROM THE IPG UP TO THE LEADS. SHE STATED THAT OVERSTIMULATION EFFECTS CAUSE HER TO FEEL AS IF SHE NEEDS A BOWEL MOVEMENT. DURING A REPROGRAMMING SESSION, THE PT ALLEGEDLY FELT THE OVERSTIMULATION SENSATION AS SOON AS SHE FELT STIMULATION. AN X-RAY WAS TAKEN BUT NO ANOMALIES WERE FOUND. THE PT REPORTED THAT HAS FALLEN FREQUENTLY. REPROGRAMMING EFFORTS WILL BE REATTEMPTED. 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 DIVISION 3788 3071749

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention