BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE S-8 LEAD, 60CM LENGTH

    MDR report key: 2193165 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-06020
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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

    THE PT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT CANNOT INCREASE HIS STIMULATION USING CONTACTS ONE THROUGH FOUR ON THE LEAD. AS SUCH, HE IS NOT RECEIVING OPTIMAL THERAPY RELIEF. A DIAGNOSTIC TEST DID NOT REVEAL ANY ISSUES WITH RESPECT TO IMPEDANCE. A NEW PROGRAM UTILIZING THE FOUR REMAINING LEAD CONTACTS WAS ISSUED TO THE PT WHICH ALLOWED FOR THE INCREASE IN STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S-8 LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3194889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL UNK| IMPLANT: