BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2130671 · Received June 14, 2011

    Report

    Report Number
    1627487-2011-00808
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 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 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 AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT LOST MOVEMENT AND FEELING IN HER LEFT LEG FROM KNEE TO TOE SHORTLY AFTER IMPLANT. FOLLOW-UP ON THIS ISSUE FOUND THAT THE PATIENT HAS BEEN DIAGNOSED WITH NEUROFIBROMATOSIS, BUT WAS REGAINING FEELING IN HER LOWER LIMB WITH PHYSICAL THERAPY. AT THIS TIME, THE PATIENT'S LEADS REMAIN IMPLANTED. A DECISION ON WHETHER SURGICAL INTERVENTION WILL BE UNDERTAKEN IN THIS MATTER HAS NOT BEEN REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3168012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention