BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44 SURGICAL LEAD

    MDR report key: 2080251 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01346
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NONCONFORMANCE RELATED TO THE PRODUCT. THE PRODUCT WAS REPLACED AND RELEASED FOR USE. THE DHR NONCONFORMANCE IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 RECEIVED HER SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2007. IT WAS REPORTED THAT DURING A REPROGRAMMING SESSION, SOME OF THE PATIENT'S LEAD CONTACTS EXHIBITED INVALID IMPEDANCE READINGS. IT WAS REPORTED THAT THE SURGEON WAS AWARE OF THIS ISSUE. THE PHYSICIAN DECIDED THAT NO ACTION WOULD BE TAKEN AT THIS TIME SINCE THE PATIENT IS RECEIVING EFFECTIVE PARESTHESIA COVERAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3244 68917

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention