BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS IMPLANTABLE PULSE GENERATOR

    MDR report key: 1834151 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-02170
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    December 8, 2009
    Report Date
    December 9, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. THE IPG AS RECEIVED IS NONFUNCTIONAL. THE IPG WILL NOT COMMUNICATE WITH A LAB PPG OR THE AUTO TESTER. WAS CONFIRMED FOR LOSS OF STIMULATION THE IPG IS NONFUNCTIONAL. 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 (B)(6) RECEIVED AN SCS SYSTEM, INCLUDING AN IPG, ON (B)(6)2009. IT WAS REPORTED THE PT FELT OVERSTIMULATION WHEN ESTABLISHING CONTACT WITH THE PROGRAMMER AND WHEN INCREASING THE IPG AMPLITUDE. THE IPG WAS EXPLANTED AND REPLACED. THE EXPLANTED IPG WAS RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3608 2746416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention