BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2143108 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-02848
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 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

    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

    THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT TWO DAYS LATER, THE PT EXPERIENCED PAIN AND NUMBNESS IN ONE FOOT. A CT SCAN WAS CONDUCTED FOLLOWING THE ONSET OF SYMPTOMS WHICH DID NOT CONFIRM THE ORIGINAL/ESTABLISH A NEW DIAGNOSIS. THE SYSTEM WAS EXPLANTED ON AN UNK DATE. IT IS POSSIBLE THAT THE PADDLE LEAD MOVED TO THE SIDE OF THE EPIDURAL SPACE AND RESULTED IN THE REPORTED SYMPTOMS. FOLLOW-UP ON THIS MATTER FOUND THAT THE PT'S SYMPTOMS ARE PARTIALLY RESOLVED BUT POSSIBLY TEMPORARILY. THE PT WILL UNDERGO REHABILITATION IN A NURSING HOME FOR A FEW WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3350866

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANT:| IPG, MODEL: 3788