BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS 8-CHANNEL IPG

    MDR report key: 1834189 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-02264
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    March 19, 2009
    Report Date
    May 18, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: - THE DEVICE HISTORY AND STERILIZATION RECORDS 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. IPG FAILED AUTOTESTER AND RANDOM OUTPUTS WERE OBSERVED ON BENCH. 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 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 (B)(6) RECEIVED THEIR SCS SYSTEM INCLUDING AN IPG ON (B)(6)2009. IT WAS REPORTED THAT THE PT EXPERIENCED OVERSTIMULATION SENSATIONS. THE IPG WAS EXPLANTED AND REPLACED ON (B)(6)2009. THE IPG WAS RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS 8-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3608 173445

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention