BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1910875 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03342
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 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 MFR. REPORT # 1627487-2010-03339. THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG AND PERCUTANEOUS LEAD. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING OVERSTIMULATION AT THE IPG POCKET WHEN RECHARGING HIS IPG. THE REPORTED SENSATION IS ALSO FELT WHEN HE UTILIZED THE MAGNET TO TURN THE STIMULATION OFF. IN ADDITION, IT WAS REPORTED THAT HIS STIMULATION TURNS ON BY ITSELF. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PATIENT. THE RESULTS OF THE INTERVENTION METHOD HAVE NOT BEEN DISCLOSED. NO FURTHER INFORMATION IS AVAILABLE.

    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 3100540

    Patients

    Seq Age Sex Outcome Treatment
    1