BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1716381 · Received June 1, 2010

    Report

    Report Number
    1627487-2010-00597
    Event Type
    Injury
    Date Received
    June 1, 2010
    Date of Event
    April 2, 2009
    Report Date
    April 3, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. THE TERMINAL END ELECTRODE IS MISSING AND THE LEAD HAS SEVERAL LOCATIONS OF OUTER TUBE DAMAGE. LEAD FAILS CONTINUITY TESTING. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 3: REFERENCE MFR REPORT # 1627487-2010-00596; 1627487-2010-00734. THE PT REC'D HIS ORIGINAL SCS SYSTEM CONSISTING OF AN IPG AND TWO PERCUTANEOUS LEADS ON (B) (6) 2006, FOLLOWED BY SYS COMPONENT CHANGES INCLUDING A NEW IPG IN (B) (6) 2008. IT WAS REPORTED THAT THE PT HAD A PROCEDURE IN (B) (6) 2009 TO RECEIVE NEW PERCUTANEOUS LEADS AND AFTERWARD BEGAN EXPERIENCING OVERSTIMULATION SENSATIONS. A LEAD IMPEDANCE TEST WAS ATTEMPTED, BUT THIS ALSO REPORTEDLY CAUSED OVERSTIMULATION FOR THE PT. THE PHYSICIAN EXPLANTED AND REPLACED THE SYS IN (B) (6) 2009 AND RETURNED THE EXPLANTED DEVICES FOR EVAL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 119134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention