BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW DUAL RECEIVER, 16-CHANNEL

    MDR report key: 1834154 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-02070
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    March 11, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 AN UNK DATE. IT WAS REPORTED THAT THE PT WAS EXPERIENCING OVERSTIMULATION. THE RECEIVER WAS REPLACED WITH AN IPG ON (B)(6)2008. F/U ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED RECEIVER WAS NOT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention