BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1925512 · Received December 7, 2010

    Report

    Report Number
    1627487-2010-03397
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVSION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2010-03396. THE PATIENT RECEIVED HIS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS), ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEVERE STABBING SENSATION TO HIS LATERAL MID BACK BILATERALLY DURING STIMULATION. PAIN WAS WORSE ON THE LEFT SIDE THAN THE RIGHT. THE PAIN CEASED WHEN STIMULATION WAS TURNED OFF. AN X-RAY TAKEN AT HIS TWO WEEK POSTOPERATIVE APPOINTMENT SHOWED THE RIGHT LEAD HAD MIGRATED DOWN ONE VERTEBRAL LENGTH. FOLLOW UP ON THE PATIENT FOUND THAT THE PATIENT WILL MEET WITH A NEUROSURGEON TO DISCUSS EXPLANTING THE LEADS AND REPLACING THEM WITH A PADDLE LEAD. 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 DIVSION 3186 3161495

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention