BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE S-8 LEAD, 60CM LENGTH

    MDR report key: 2201484 · Received August 4, 2011

    Report

    Report Number
    1627487-2011-06045
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K022222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 (B)(6) RECEIVED AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. A DIAGNOSTIC TEST REVEALED THAT CONTACTS ONE AND EIGHT OF THE LEAD WERE NOT FUNCTIONAL. EFFECTIVE STIMULATION WAS REPORTEDLY RECAPTURED VIA REPROGRAMMING. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S-8 LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3299786

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT:| SCS LEAD EXTENSION: MODEL 3383| IMPLANT:| SCS IPG: MODEL UNKNOWN