BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW DUAL RECEIVER, 16-CHANNEL

    MDR report key: 1870785 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02080
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    April 1, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). 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 RECEIVED HER SCS SYSTEM INCLUDING A NEUROSTIMULATOR RECEIVER ON (B)(6) 2002. IT WAS REPORTED THAT STIMULATION WOULD TURN OFF AFTER SEVERAL SECONDS OF TURNING IT ON. THE RECEIVER WAS REPLACED ON (B)(6) 2008. FOLLOW UP ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED RECEIVER WAS NOT RETURNED TO ANS FOR EVALUATION. 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 13205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention