BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2003987 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-01183
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 3 OF 3. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01181 AND 1627487-2011-01182. THE PT REC'D HIS SCS SYSTEM CONSISTING OF TWO PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS) ON (B)(6) 2010 AND TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) AND AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT THE PT FELT STRONG SURGES OF OVERSTIMULATION AT TIMES. THE PT STATED THIS HAPPENS WITH STIMULATION ON OR OFF, AND THE PT CLAIMED THAT THIS LASTS 5-10 MINUTES. IT WAS REPORTED THAT THE PHYSICIAN WOULD BE NOTIFIED OF THE ISSUE. THE NEXT COURSE OF ACTION FOR THE PT IS CURRENTLY UNDETERMINED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL- NEUROMODULATION DIVISION 3186 3170781

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention