BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C LEAD, 60CM

    MDR report key: 1790706 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01595
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    June 3, 2009
    Report Date
    June 5, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. 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. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS A 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 2. REFERENCE MFR REPORT # 1627487-2010-01594. THE PT RECEIVED HER SCS SYSTEM INCLUDING A PADDLE LEAD AND IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE LEAD MIGRATED. THE LEAD WAS REPOSITIONED ON (B)(6) 2009. FOLLOW UP FOUND THAT THERE WERE DIFFICULTIES CAPTURING HER BACK PAIN DURING PROGRAMMING. THE PHYSICIAN DID NOT WANT TO EXPLANT THE SYSTEM DUE TO EXISTING SCAR TISSUE AND PREVIOUS MULTIPLE SURGERIES THE PT HAD. THEY WOULD ONLY EXPLANT IF ANY FURTHER PROBLEMS REPORTED BY THE PT. FURTHER FOLLOW UP FOUND THAT THE PHYSICIAN DID EXPLANT THE SYSTEM ON (B)(6) 2010 AS REPORTED IN FULL ON MFR REPORT #1627487-2010-00424 SUBMITTED IN MAY 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16C LEAD, 60CM SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3214 2754417

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention