BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXESS PERCUTANEOUS LEAD

    MDR report key: 2143106 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-02851
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 RECEIVED HIS SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION UP TO A CERTAIN AMPLITUDE, THEN HE FELT OVERSTIMULATION ABOVE THAT AMPLITUDE. X-RAYS REVEALED THAT THE PATIENT'S LEAD HAD MIGRATED. THE PHYSICIAN PLANS TO EXPLANT AND REPLACE THE LEAD; HOWEVER, THE SURGERY DATE IS CURRENTLY UNDETERMINED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXESS PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 4146 3166271

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS EXTENSION: MODEL 3383| SCS IPG: MODEL 3788