BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2251526 · Received September 14, 2011

    Report

    Report Number
    1627487-2011-05143
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 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

    RESULTS: THE PRODUCT WAS RECEIVED INCOMPLETE. THE LEAD WAS MICROSCOPICALLY EXAMINED AND NO BROKEN WIRES WERE OBSERVED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE LEAD BEING CUT. 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. REF MFR REPORT: 1627487-2011-05142. THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2008 WITH TWO PERCUTANEOUS LEADS (FROM DIFFERENT LOTS). IT WAS REPORTED THAT THE PT'S LEADS WERE EXPLANTED AND REPLACED DUE TO INEFFECTIVE STIMULATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    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 98105

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3716