BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16C LEAD

    MDR report key: 1870766 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-01776
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. A REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT, HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). 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 MANUFACTURER'S REPORT: 1627487-2010-01775. THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THE PT HAD HIGH IMPEDANCES ON THE IMPLANTED LEAD. AS A RESULT, THE IPG COULD NOT PROVIDE ENOUGH OUTPUT TO COVER THE PT'S PAIN. THE PT REQUESTED A SYSTEM REPLACEMENT. THE PHYSICIAN HAD ADVISED THE PT THAT THE HIGH IMPEDANCES WERE AN ANATOMICAL PROBLEM NOT A PRODUCT PROBLEM; HOWEVER, THE PT PERSISTED. THE IPG AND LEAD WERE EXPLANTED AND REPLACED. THE EXPLANTED SYSTEM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW UP ON THE PT FOUND THE NEW LEAD ALSO HAD HIGH IMPEDANCES; THE NEW SYSTEM REMAINS IN USE.

    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 83151

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention