BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 4 LEAD, 90CM LENGTH

    MDR report key: 2100731 · Received May 18, 2011

    Report

    Report Number
    1627487-2011-00687
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 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
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. AS RECEIVED, THERE WAS A BROKEN WIRE VISIBLE INSIDE THE LEAD BODY. THE LEAD MEASURED OPEN AT CHANNEL 7. ALL OTHER CHANNELS MEASURED WITHIN SPECIFICATIONS. THE ALLEGATION OF PAIN AT THE IPG SITE COULD NOT BE INVESTIGATED BASED ON THE PRODUCTS RETURNED FOR ANALYSIS. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT (B)(6) RECEIVED AN SCS SYSTEM FOR PAIN IN BOTH LEGS INCLUDING A SURGICAL LEAD ON (B)(6) 2007. IT WAS REPORTED THAT SHE WAS NOT RECEIVING EFFECTIVE THERAPY RELIEF. IN ADDITION, IT WAS ALLEGED THAT THE PT WAS EXPERIENCING PAIN AT THE IPG SITE. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PT'S LEAD. FOLLOW-UP ON THIS MATTER FOUND THAT EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT AS A RESULT OF THE PROCEDURE. IN ADDITION, THE PAINFUL SENSATION AT THE IPG SITE IS REPORTEDLY NO LONGER PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 4 LEAD, 90CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3254 69949

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT:| SCS IPG: MODEL UNK