BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44C SURGICAL LEAD

    MDR report key: 2051341 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-02414
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT REC'D HIS SCS SYS, INCLUDING A SURGICAL LEAD, ON (B)(6) 2006. IT WAS REPORTED THE PT IS SUDDENLY FEELING STIMULATION IN HIS STOMACH AND NO LONGER FEELS ANY STIMULATION IN HIS LEGS. THE PT IS WORKING WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION. AT THIS TIME, THE PHYSICIAN HAS INDICATED HE WOULD LIKE TO ATTEMPT TO REPROGRAM THE SCS SYS. NO FURTHER PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44C SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3245 33490

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention