BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESISXP IMPLANTABLE PULSE GENERATOR

    MDR report key: 1870745 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02319
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    January 26, 2010
    Report Date
    January 27, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: 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. 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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2004. IT WAS REPORTED THE PT LOST STIMULATION AND COMMUNICATION FUNCTIONALITY WITH THE IPG. THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2010. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED. THE IPG WAS NOT RETURNED TO ANS FOR EVAL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISXP IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3644 24195A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention