BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITROD 8 SURGICAL LEAD

    MDR report key: 1940594 · Received December 21, 2010

    Report

    Report Number
    1627487-2010-03856
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCLUSION: 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

    IT WAS REPORTED THAT DURING AN IMPLANT/REPLACEMENT PROCEDURE FOR A SURGICAL LEAD, AN IMPEDANCE CHECK SHOWED HIGH IMPEDANCE LEVELS FOR TWO LEAD CONTACTS. DURING SURGICAL PROCEDURE, A LATER READING SHOWED INVALID IMPEDANCE LEVELS ACROSS ALL LEAD CONTACTS EXCEPT FOR TWO. A FINAL IMPEDANCE CHECK REVEALED A HIGH READING FOR TWO LEAD CONTACTS. SINCE THE PATIENT HAD BEEN ON THE OPERATING TABLE FOR THREE HOURS, THE PHYSICIAN DECIDED TO CONNECT THE SURGICAL LEAD TO THE IPG AND ATTEMPT PROGRAMMING LATER IN THE WEEK AFTER THE PATIENT RECOVERED FROM SURGERY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITROD 8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3280 175110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention