BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1936151 · Received December 13, 2010

    Report

    Report Number
    1627487-2010-03908
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 22, 2010
    Report Date
    November 11, 2010
    Manufacturer
    SJM NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION WAS NOT PERFORMED AS PRODUCT ANALYSIS CANNOT CONFIRM OR NOT CONFIRM THE ALLEGED LEAD MIGRATION. SJM HAS LIMITED INFO 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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PT WAS EXPERIENCING UNCOMFORTABLE STIMULATION IN HER LOWER BACK. AN X-RAY SHOWED THAT ONE LEAD HAD MIGRATED. THE PT WAS REPROGRAMMED USING THE OTHER LEAD AND ADEQUATE COVERAGE WAS OBTAINED; HOWEVER, THE PATIENT'S STIMULATION CHANGED AT A LATER DATE. THE PERCUTANEOUS LEADS WERE REPLACED WITH A PADDLE LEAD ON (B)(6) 2010. THE EXPLANTED LEADS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW SJM NEUROMODULATION DIVISION 3186 3163464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention