BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790723 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01609
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    May 7, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. EVALUATION: 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. THE IPG PASSES THE AUTO TEST. THE IPG HAS A MINOR CUT TO THE HEADER MATERIAL BUT OTHERWISE APPEARS IN GOOD CONDITION. 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

    DEVICE 1 OF 2. REFERENCE MANUFACTURER'S REPORT: 1627487-2010-01610. THE PATIENT RECEIVED HIS SCS SYSTEM CONSISTING OF AN IPG, 2 PERCUTANEOUS LEADS AND AN EXTENSION ON (B)(6)2008. IT WAS REPORTED THAT THE PATIENT HAD A PROCEDURE TO HAVE HIS IPG REPLACED DUE TO A DEPLETED BATTERY. IN THE RECOVERY ROOM, IMPEDANCE TESTING SHOWED LOW IMPEDANCES ON ALL CONTACTS AND THE PATIENT COULD NOT FEEL STIMULATION. THE PATIENT WAS REPORTEDLY TAKEN BACK TO THE OPERATING ROOM AND THE PHYSICIAN TESTED THE EXTENSION AND OBSERVED INVALID IMPEDANCES. HE REMOVED THE EXTENSION AND TESTED THE PATIENT'S LEADS. THE PHYSICIAN AGAIN OBSERVED INVALID IMPEDANCES WHEN TESTING THE LEADS DIRECTLY. THE IPG AND THE EXTENSION WERE REPLACED. THE EXPLANTED IPG WAS RETURNED TO ANS FOR ANALYSIS. NO FURTHER INFORMATION IS 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 97154

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention