BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3161450 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-15766
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    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

    IT WAS REPORTED THE PATIENT EXPERIENCED LEFT LEG WEAKNESS SUBSEQUENT TO HAVING HER SCS LEAD REPLACED. DURING THE LEAD REPLACEMENT PROCEDURE, SOMATOSENSORY EVOKED POTENTIAL (SSEP) MONITORING INDICATED A SLIGHT LOSS ON THE LEFT SIDE AND THE FOLLOWING DAY, THE PATIENT STILL HAD SOME LEFT LEG WEAKNESS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A CT SCAN WAS PERFORMED. THE CT SCAN SHOWED THE LEAD WAS IN THE IMPLANT LOCATION. FOLLOW-UP INFORMATION INDICATED THE PATIENT'S LEFT LEG WEAKNESS HAS SINCE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249212 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3901040

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R SCS IPG: MODEL 3788| IMPLANT DATE: