BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1936226 · Received December 14, 2010

    Report

    Report Number
    1627487-2010-03951
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    SJM NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 2 OF 2. REFERENCE # 1627487-2010-03912. THE PT RECEIVED HER SCS SYS ON (B)(6) 2005. IT WAS REPORTED THAT THE PT NEEDED BETTER COVERAGE. THE PT SAID THAT SHE COULD FEEL THE LEADS PULLING AND THAT THE IPG FELT TOO BIG. THE SYS WAS REPLACED ON (B)(6) 2010. THE EXPLANTED DEVICES WERE RETURNED TO THE MFR FOR ANALYSIS. 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 39835

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention