BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS 8-CHANNEL IPG

    MDR report key: 1790692 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01631
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    September 10, 2009
    Report Date
    September 10, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE ATTEMPTED IMPLANT OF AN IPG AND PERCUTANEOUS LEAD INTO THIS PATIENT OCCURRED ON (B)(6) 2009. IT WAS REPORTED THAT PRIOR TO CLOSING THE IPG POCKET SITE, THE PATIENT CRASHED ON THE TABLE. THIS NECESSITATED THE PHYSICIAN TO ROLL THE PATIENT OVER (COMPROMISING STERILITY) IN ORDER TO RESUSCITATE HIM. THE SYSTEM WAS REMOVED AND WITH THE INTENT OF ANOTHER SYSTEM BEING IMPLANTED AT A LATER DATE. FOLLOW UP WITH THE PATIENT FOUND THAT HE IS DOING FINE. 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 2799114

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention