BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1991101 · Received February 11, 2011

    Report

    Report Number
    1627487-2011-02191
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    June 30, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MFR REPORT: 1627487-2011-02168. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2005. IT WAS REPORTED THE PT BEGAN EXPERIENCING PAIN AT THE LEAD SITE SHORTLY AFTER FALLING OFF A LADDER. THE LEAD WAS EXPLANTED AND REPLACED. UNFORTUNATELY, THE LOT NUMBER FOR THE EXPLANTED LEAD WAS NOT PROVIDED; THEREFORE, A REPORT HAS BEEN SUBMITTED FOR BOTH LEADS. THE EXPLANTED LEAD WAS NOT RETURNED TO THE MFR FOR ANALYSIS. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3186 39835

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention