BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 30-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2153362 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-03150
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE IMPLICATED DEVICE WAS NOT RETURNED FOR INVESTIGATION. SJM HAS LIMITED INFORMATION 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-03203. THE PT REC'D AN SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT HAD LOST STIMULATION AND COULD NOT TURN THE STIMULATION UP TO PERCEPTION LEVEL ON ANY PROGRAMS. ALL CONTACTS WERE INVALID. X-RAY WAS TAKEN AND CONFIRMED THAT THERE WAS NO MIGRATION, DISCONNECTION AND FRACTURE. UPON SURGERY, IT WAS FOUND THAT THE IPG WAS FUNCTIONING PROPERLY WHILE THE LEADS WERE EXPLANTED AND REPLACED DUE TO INVALID IMPEDANCE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 30-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3250316

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention