BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW RECEIVER

    MDR report key: 1870539 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02132
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    December 18, 2008
    Report Date
    January 5, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 PATIENT (UNITED KINGDOM) RECEIVED AN SCS SYSTEM INCLUDING A NEUROSTIMULATOR RECEIVER. IT WAS REPORTED THAT THE PATIENT EXPERIENCED OVERSTIMULATION AND INTERMITTENT STIMULATION THAT WAS NOT RESPONSIVE TO REPROGRAMMING. THE RECEIVER WAS EXPLANTED ON (B)(6)2008. DURING THE REVISION, BOTH LEADS WERE TESTED AND FOUND TO HAVE NORMAL IMPEDANCES. THE PHYSICIAN REPORTED OBSERVING FLUID INGRESS IN THE HEADER OF THE RECEIVER. THE EXPLANTED RECEIVER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW RECEIVER IMPLANTABLE PULSE GENERATOR GZB ADVANCED NEUROMODULATION SYSTEMS 3416 34931A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention