BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL CORD STIMULATION LEAD

    MDR report key: 2033534 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-01294
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 ((B)(6)) RECEIVED HIS SCS SYSTEM ON (B)(6) 2010 FOR LEFT LOWER EXTREMITY PAIN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CHANGE IN STIMULATION AND FELT STIMULATION TO HIS LOWER BACK AND RIGHT SIDE. AN X-RAY SHOWED MIGRATION OF THE PATIENT'S LEAD. THE PHYSICIAN PLANS TO EXPLANT AND REPLACE THE LEAD IN THE FUTURE. A SURGERY DATE IS CURRENTLY UNDETERMINED; NO FURTHER INFORMATION IS AVAILABLE. THE MODEL AND LOT NUMBERS OF THE LEAD WERE NOT REPORTED AND FOLLOW UP ATTEMPTS WERE UNSUCCESSFUL IN OBTAINING THIS INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3608