BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW DUAL RECEIVER, 16 CHANNEL

    MDR report key: 1790834 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01667
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 21, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE RECEIVER PASSES BOTH THE MANUAL TEST AND THE AUTO TEST. THE RECEIVER APPEARS IN GOOD CONDITION. THE RECEIVER WAS RETURNED WITHOUT THE TRANSMITTER OR WAND. 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 PATIENT RECEIVED HER SCS SYSTEM INCLUDING A NEUROSTIMULATOR RECEIVER ON (B)(6) 2005. IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING PROBLEMS INCLUDING LOSS OF STIMULATION AND DIFFICULTY COMMUNICATING BETWEEN THE RECEIVER AND THE WAND. THE RECEIVER WAS REPLACED WITH A TOTALLY IMPLANTABLE PULSE GENERATOR (IPG) ON (B)(6) 2008. THE EXPLANTED RECEIVER WAS RETURNED TO ANS FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW DUAL RECEIVER, 16 CHANNEL SPINAL CORD STIMULATION RECEIVER LGW ADVANCED NEUROMODULATION SYSTEMS 3416 36582A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention