BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA LEAD

    MDR report key: 2212639 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-02928
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2011-02927. THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED AND REPLACED ON (B)(6) 2011. THE PATIENT HAD FALLEN TWICE SEVERAL MONTHS AGO AND HIS STIMULATION PATTERN HAD SUBSEQUENTLY CHANGED. IN ADDITION, HE EXPERIENCED DISCOMFORT/BURNING SENSATION NEAR THE IPG SITE AND FOLLOWING THE LEAD TOWARD THE CENTER OF THE LOW BACK WHEN STIMULATION WAS ON. THE EXPLANTED PRODUCTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3288 2870862

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention