BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA LEAD

    MDR report key: 2133636 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-02836
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT AFTER THE PROCEDURE, PROGRAMMING WOULD ONLY ALLOW RIGHT SIDE COVERAGE. AN X-RAY SHOWED THAT THE LEAD HAD MIGRATED. ON (B)(6) 2011, THE LEAD WAS SURGICALLY REPOSITIONED. COVERAGE WAS SIGNIFICANTLY IMPROVED AFTER THE PROCEDURE. NO ADDITIONAL INFO 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 3228 3269068

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT:| IPG: MODEL 3788