BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW DUAL RECEIVER, 16 CHANNEL

    MDR report key: 1633924 · Received March 5, 2010

    Report

    Report Number
    1627487-2010-00081
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    February 3, 2010
    Report Date
    February 5, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED, NO ANOMALIES WERE FOUND. RESULTS: ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. CONCLUSION: THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    IT WAS REPORTED THAT THE PATIENT FELT INTERMITTENT SHOCKING A COUPLE OF MONTHS AGO, AND THEN THE RECEIVER NO LONGER PROVIDED STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW DUAL RECEIVER, 16 CHANNEL IMPLANTABLE SPINAL CORD STIMULATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3416 153521A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other