BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2092659 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-01492
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 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 INFO 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 1 OF 3. REFERENCE MFR REPORT: 1627487-2011-01493 AND 1627487-2011-01494. THE PT RECEIVED HER SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS) AND TWO ANCHORS (FROM THE SAME LOT), ON (B)(6) 2011. THE PT'S PAIN PATTERN IS LEFT THIGH, LOW BACK AND LEFT LOWER EXTREMITY (HIP TO ANKLE). IT WAS REPORTED THAT THE PT COMPLAINED OF GENERALIZED POSTSURGICAL PAIN AND WAS SEEN BY THE PHYSICIAN ON (B)(6) 2011. THE PT REPORTED STIMULATION IN HER STOMACH AND RIBS AND OVERALL INEFFECTIVE STIMULATION COVERAGE. AN X-RAY SHOWED ON ONE OF THE LEADS HAD MIGRATED. THE PHYSICIAN PERFORMED A REVISION PROCEDURE ON (B)(6) 2011. HE NOTED THAT THE MIGRATED LEAD'S ANCHOR WAS NOT LOCKED. THE PHYSICIAN LOCKED THE ANCHOR, AND INTRAOPERATIVE TESTING RESULTED IN TARGETED PAIN COVERAGE. F/U ON THE PT FOUND THAT SHE REPORTED EFFECTIVE STIMULATION, AND NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3186 3301965

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: