BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE S8 SURGICAL LEAD

    MDR report key: 2093174 · Received April 14, 2011

    Report

    Report Number
    1627487-2011-01395
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT REC'D HIS SCS SYS, INCLUDING A SURGICAL LEAD, ON (B)(6) 2009. IT WAS REPORTED THAT THE PT LOST STIMULATION, AND THE AMPLITUDE STOPPED AT PERCEPTION ON ALL OF THE PT'S PROGRAMS. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE READINGS ON 6 OF THE 8 LEAD CONTACTS. THE PHYSICIAN PLANS TO PERFORM A REVISION OR EXPLANT/REPLACEMENT PROCEDURE; HOWEVER, THE SURGERY DATE IS CURRENTLY UNDETERMINED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD GZB ST JUDE MEDICAL - NEUROMODULATION DIVISION 3268 119993

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention