BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3201921 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-15856
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    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

    IT WAS REPORTED, THE PATIENT WAS EXPERIENCING PAIN IN HIS RIGHT THIGH. THE PATIENT STATED, HE HAS STIMULATION IN BOTH LEGS, BUT THE STIMULATION IN HIS RIGHT THIGH IS INEFFECTIVE AND NOT HELPING HIS PAIN. THE PATIENT ALSO STATED, THE PAIN IS LIKE THE PAIN HE EXPERIENCED BEFORE HIS SCS SYSTEM WAS IMPLANTED. THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING BUT WAS UNABLE TO OBTAIN SUFFICIENT STIMULATION TO THE RIGHT THIGH. THE PATIENT WAS GIVEN A BACK BRACE FOR ADDED SUPPORT AND TO RELIEVE POTENTIAL STRAIN AND MAY BE SENT FOR PAIN INJECTIONS IF THE PAIN CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290612 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3847676

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1194 (2)| SCS IPG: MODEL 3788