BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2033504 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-00398
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS CORRECTED AND THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE REPORTED EVENT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 #S 1627487-2011-00406 AND 1627487-2011-00407. THE PT WAS IMPLANTED WITH AN SCS SYSTEM ON (B)(6) 2011, INCLUDING AN IPG SINGLE PERCUTANEOUS LEAD, AND A LEAD ANCHOR. IT WAS REPORTED THAT THE PT EXPERIENCED NUMBNESS IN HER LEFT LEG SHORTLY AFTER IMPLANT. HER SCS SYS WAS EXPLANTED AS A RESULT. FURTHER INVESTIGATION REVEALED THAT THE PT HAD A CONTUSION ON HER SPINAL CORD; HOWEVER, NO HEMATOMA WAS PRESENT. F/U ON THIS MATTER FOUND THAT THERE WAS SIGNIFICANT IMPROVEMENT REGARDING THE REPORTED SYMPTOMS ONCE THE PT'S LEAD WAS REMOVED. NO FURTHER INFO IS AVAILABLE. THE EXPLANTED PRODUCTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3186 3157455

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R