BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1910970 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03312
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE PT REC'D HIS SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT ABOUT ONE MONTH LATER, THE PT FELT A TINGLING SENSATION AND RANDOM SHOCKS IN HIS ARM/LEGS UPON TURNING OFF HIS IPG. PT REPROGRAMMING EFFORTS WERE UNSUCCESSFUL IN RESOLVING THE ISSUE. THE PT CONTINUED TO FEEL THE TINGLING SENSATION WHEN NO STIMULATION WAS PRODUCED FROM THE IPG. THE PT IS SCHEDULED TO SEE THE PHYSICIAN FOR EVAL. NO FURTHER INFO 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 2829840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention