BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8 SURGICAL LEAD

    MDR report key: 2113501 · Received May 31, 2011

    Report

    Report Number
    1627487-2011-01578
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 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
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: TWO LEADS WERE RETURNED. VISUAL ANALYSIS NOTED MINOR DISCOLORATION ON THE STIMULATION END OF LEAD "A". FUNCTIONAL TESTING OBSERVED THAT BOTH LEADS HAD MULTIPLE OPEN CHANNELS. 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

    IT WAS REPORTED THAT THE PATIENT ((B)(6)) DID NOT FEEL PARESTHESIA EVEN WHEN THE AMPLITUDE WAS INCREASED. DIAGNOSTIC TESTS SHOWED BOTH SURGICAL LEADS EXHIBITED INVALID IMPEDANCE MEASUREMENTS ON MULTIPLE CONTACTS. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE LEEDS WITH A DIFFERENT MODEL ON (B)(6) 2011. EFFECTIVE STIMULATION WAS REPORTED POSTOPERATIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3283 2841265

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANT:| SCS LEAD ANCHOR: MODEL 1194