BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 30CM LENGTH

    MDR report key: 2143111 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-02845
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    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 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 RECEIVED HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT WHEN SHE ADJUSTS HER STIMULATION WITH THE PT PROGRAMMER, SHE EXPERIENCES OVERSTIMULATION. A NEW PT PROGRAMMER WAS SENT TO THE PT BUT DID NOT RESOLVE THE PROBLEM. A DIAGNOSTIC TEST REVEALED LOW IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS. AN X-RAY OF THE PT'S SCS SYSTEM WILL BE SCHEDULED FOR FURTHER INTERROGATION. FOLLOW-UP ON THIS MATTER FOUND THAT THE PT IS REPORTEDLY USING THE STIMULATION AS IS; THE NEXT COURSE OF ACTION IN THIS MATTER REMAINS UNDECIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 30CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 2796266

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS IPG, MODEL: 3788| SCS LEAD, MODEL: 3183| IMPLANT:| IMPLANT:| SCS IPG, MODEL: 3788| IMPLANT: