BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW DUAL RECEIVER, 16-CHANNEL

    MDR report key: 1870673 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02124
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    October 10, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD: 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. RECEIVER GAVE ERRATIC OUTPUT AND THEN STOPPED OUTPUTTING SIGNALS. 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 PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2004. IT WAS REPORTED THAT THE PT WAS NOT RECEIVING ANY STIMULATION. THE PT WAS HAVING REMOVAL OF BOTH LEADS AND RECEIVER DUE TO AN UPCOMING MRI. THE RECEIVER AND LEADS WERE RETURNED TO ANS FOR EVAL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW DUAL RECEIVER, 16-CHANNEL SPINAL CORD STIMULATION RECEIVER GZB ADVANCED NEUROMODULATION SYSTEMS 3416 200431A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention