BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2092868 · Received May 11, 2011

    Report

    Report Number
    1627487-2011-01505
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 HER SCS TRIAL SYSTEM ON (B)(6) 2011. THE TRIAL SYSTEM WAS EXPLANTED ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF SIGNIFICANT PAIN ON (B)(6) 2011, BUT SHE DID NOT CHARACTERIZE OR INDICATE WHERE THE PAIN WAS FELT. SHE WILL FOLLOW UP WITH HER PHYSICIAN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL- NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention