BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW DUAL RECEIVER, 16-CHANNEL

    MDR report key: 1790639 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01330
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    November 10, 2008
    Report Date
    November 10, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 SPECS AND NO ANOMALIES WERE FOUND. THE RECEIVER FAILED THE MANUAL TEST AND THE AUTO TEST. IT IS POSSIBLE THE COMPONENTS IN ONE OR BOTH HYBRIDS MAY HAVE FAILED. 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 CONSISTING OF A NEUROSTIMULATION RECEIVER AND TWO PERCUTANEOUS LEADS IN 2006. IT WAS REPORTED THAT THE PT WAS EXPERIENCING OVERSTIMULATION. AN X-RAY CONFIRMED THAT THE SYSTEM CONNECTIONS WERE INTACT. THE RECEIVER WAS REPLACED WITH AN IPG ON (B)(6) 2008. FOLLOW-UP ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE RECEIVER WAS RETUNED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention