BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE TRIAL LEAD KIT, 60CM LENGTH

    MDR report key: 1980332 · Received February 2, 2011

    Report

    Report Number
    1627487-2011-00133
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    September 17, 2010
    Report Date
    January 5, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 1 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00134. ON 1/05/2011 THE MFR BECAME AWARE OF THE FOLLOWING EVENT. ON (B)(6) 2010 THE PT UNDERWENT A TRIAL PROCEDURE. AT THAT TIME, TWO PERCUTANEOUS TRIAL LEADS WERE IMPLANTED. IT WAS REPORTED THAT THE TRIAL LEADS WERE EXPLANTED WITHIN 24 HRS DUE TO ALLEGED NERVE DAMAGE WHICH WAS SAID TO HAVE OCCURRED DURING IMPLANT. THE PT WAS ALLEGEDLY UNABLE TO WALK FOLLOWING THE PROCEDURE, AND SPENT THE NEXT 6 WEEKS IN A REHABILITATION FACILITY. F/U ON THE PT FOUND THAT HE CLAIMS TO BE ABLE TO WALK NOW BUT HAS SOME REMAINING DEFICIT IN HIS UPPER LEG AREA. THE IMPLANTING PHYSICIAN WAS CONTACTED ON (B)(6) 2011 FOR MORE SPECIFICS REGARDING THIS MATTER. HE STATED THAT THE PT SUFFERS FROM SEVERE SPINAL STENOSIS AND AS SUCH, THE TRIAL WAS DEEMED UNSUCCESSFUL AND THE LEADS WERE REMOVED AS A RESULT. ACCORDING TO THE PHYSICIAN, THE IMPLANT WAS PERFORMED W/O INCIDENT. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE TRIAL LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3086 3153773

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention