BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 3221551 · Received July 9, 2013

    Report

    Report Number
    1627487-2013-06587
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 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

    THE PATIENT HAS TWO SCS EXTENSIONS FROM THE SAME LOT NUMBER. IT WAS REPORTED, THE PATIENT ALLEGES HER SCS EXTENSIONS ARE CAUSING DISCOMFORT. THE PATIENT STATED SHE CAN FEEL THE EXTENSIONS AND THAT IS IT BOTHERSOME. NO NEXT COURSE OF ACTION IS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313733 SINGLE EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3386 3286257

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other SCS LEAD, MODEL 3186| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788