BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3161442 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-15764
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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 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 PATIENT REPORTED HE IS EXPERIENCING INEFFECTIVE STIMULATION. THE PATIENT STATED HE FELT STIMULATION IN HIS LEGS, BUT NOT IN HIS BACK. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMING WAS NOT ABLE TO PROVIDE STIMULATION IN THE PATIENT'S BACK. THE PATIENT INDICATED HE IS SATISFIED WITH THE STIMULATION AND THE RELIEF IT PROVIDES FOR HIS LEG PAIN. THE PATIENT DOES NOT WISH TO PURSUE SURGICAL INTERVENTION FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249038 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3763707

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention IMPLANT DATE:| SCS ANCHOR, MODEL 1192| SCS IPG: MODEL 3788| IMPLANT DATE: