BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2010851 · Received March 3, 2011

    Report

    Report Number
    1627487-2011-01198
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    September 28, 2010
    Report Date
    February 4, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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. LEAD "A" WAS NOT TO HAVE OUTER TUBE COMPRESSION DAMAGE. LEAD "A" PASSED ALL FUNCTIONAL TESTING. LEAD "B" WAS RETURNED SEVERELY KINKED WITH ALL WIRES BROKEN APPROXIMATELY 27 CM FROM THE STIMULATION END. THE LEAD WAS ALSO NOTED TO HAVE COMPRESSION DAMAGE. DUE TO THE BROKEN WIRES IN THE LEAD SEGMENT, FUNCTIONAL TESTING COULD NOT BE PERFORMED ON LEAD "B". 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 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

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01197. THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS), ON (B)(6) 2010. IT WAS REPORTED THAT THE PT EXPERIENCED A FALL AND WAS KNOCKED UNCONSCIOUS APPROXIMATELY FIVE MONTHS AGO. AFTER THE FALL, SHE STATED THAT ONE OF HER LEAD CONTACTS MEASURED INVALID IMPEDANCE. IT WAS REPORTED THAT SHE WAS REPROGRAMMED, BUT SHE GRADUALLY LOST EFFECTIVE STIMULATION UNTIL EVENTUALLY ALL OF HER LEAD CONTACTS WERE READING INVALID IMPEDANCE FOR ONE OF THE LEADS. THE PHYSICIAN EXPLANTED AND REPLACED BOTH OF THE PT'S LEADS ON (B)(6) 2011. IT WAS REPORTED DURING THE EXPLANT PROCEDURE THAT ONE OF THE LEADS APPEARED TO HAVE A FRACTURE NEAR THE ANCHOR SITE. THE EXPLANTED LEADS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES WERE REPORTED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3186 3087459

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention