BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 30-CM LENGTH SURGICAL LEAD

    MDR report key: 2140946 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-03115
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    PT RECEIVED A SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT WAS WITHOUT STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS. AN X-RAY WAS TAKEN AND REVEALED A POSSIBLE LEAD FRACTURE NEAR THE LEAD ENTRY INTO EPIDURAL SPACE. THE PT HAS BEEN REFERRED TO A DOCTOR FOR A PADDLE LEAD REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 30-CM LENGTH SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3203870

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention SCS EXTENSION: MODEL 3383| IMPLANTED:| SCS IPG: MODEL 3788| IMPLANTED: