BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 SURGICAL LEAD

    MDR report key: 2091633 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-01459
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT¿S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT¿S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT¿S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2010 FOR BILATERAL LEG AND LOW BACK PAIN. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF RIGHT SIDE ABDOMINAL AND FLANK PAIN. REPROGRAMMING EFFORTS HAVE BEEN UNSUCCESSFUL AT RESOLVING THE ISSUE. THE PATIENT PLANS TO MEET WITH HIS PHYSICIAN TO DISCUSS THE NEXT COURSE OF ACTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. ACCORDING TO THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM, THE PATIENT'S SYSTEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3219 3117469

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCS LEAD EXTENSION: MODEL 3386| SCS IPG: MODEL 3788| IMPLANTED:| IMPLANTED: