BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16C LEAD

    MDR report key: 1870679 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02274
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    June 30, 2008
    Report Date
    July 15, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. CONCLUSION: - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FORM 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 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A TRIAL LEAD PLACEMENT TO ASSESS THE EFFECTIVENESS OF AN SCS SYSTEM TO RELIEVE HIS PAIN ON (B)(6) 2008. IT WAS REPORTED THAT DURING THE TUNNELING PROCESS OF THE LEAD, WHEN THE TUNNELER WAS REMOVED THE OUTER SLEEVE WAS DISLODGED UNDER THE PT'S SKIN AND WAS UNABLE TO BE RETRIEVED AT THAT TIME. DURING THE PERMANENT PLACEMENT OF THE IPG ON (B)(6) 2008, THE PHYSICIAN LOCATED AND REMOVED THE SLEEVE. THE TUNNELING SLEEVE WAS EXPLANTED AND NOT RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16C LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3214 118159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention