BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAMITRODE TRIPOLE 8 SURGICAL LEAD

    MDR report key: 2020227 · Received March 10, 2011

    Report

    Report Number
    1627487-2011-02278
    Event Type
    Other
    Date Received
    March 10, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 AN SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2011. POSTOPERATIVE, IT WAS NOTED BY THE MANUFACTURER'S REPRESENTATIVE THAT THE IMPLANTED LEAD HAD EXPIRED. THE PHYSICIAN WAS NOTIFIED AND HAS ELECTED TO LEAVE THE LEAD IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL- NEUROMODULATION 3208 R173962

    Patients

    Seq Age Sex Outcome Treatment
    1 Other