BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S-SERIES SURGICAL LEAD

    MDR report key: 1870562 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02189
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    June 24, 2009
    Report Date
    June 24, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. ANS 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE: MANUFACTURER REPORT 1627487-2010-02188. THE PATIENT ((B)(6)) RECEIVED HIS SCS SYSTEM, WHICH INCLUDED ONE SURGICAL LEAD, ONE LEAD EXTENSION AND AN IPG, ON (B)(6) 2009. THE MODEL NUMBER OF THE SURGICAL LEAD WAS NOT PROVIDED AT THE TIME OF THE REPORT. IT WAS REPORTED THE PATIENT INVOLVED IN AN ACCIDENT WHICH LEAD TO A FALL. THE PATIENT REPORTED THAT AFTER THE ACCIDENT, HE COULD NO LONGER FEEL STIMULATION FROM HIS IPG. EXAMINATION OF THE PATIENT FOUND HIS LEAD HAD MIGRATED FROM T7 TO T4. DURING THE REVISION PROCEDURE ON (B)(6) 2009, IPG HAD INVALID AND UNSTABLE IMPEDANCES. THE IPG WAS EXPLANTED AND REPLACED AND THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S-SERIES SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention