BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60 CM LENGTH

    MDR report key: 1942649 · Received December 13, 2010

    Report

    Report Number
    1627487-2010-03925
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    SJM NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING OVERSTIMULATION AND PREVIOUSLY HAD A REVISION FOR THIS REASON. THE PATIENT IS AGAIN EXPERIENCING OVERSTIMULATION. X-RAYS SHOWED THAT ONE OF THREE LEADS HAD MIGRATED. THE PATIENT IS PLANNING ON HAVING THE ENTIRE SYSTEM REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60 CM LENGTH SPINAL CORD STIMULATION LEAD LGW SJM NEUROMODULATION DIVISION 3186 116236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention