BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1963698 · Received December 21, 2010

    Report

    Report Number
    1627487-2010-03875
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2010-03876. THE PT REC'D HIS SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG AND SURGICAL LEAD. IT WAS REPORTED THAT HE IS RECEIVING INTERMITTENT STIMULATION. THE THERAPY IS ALLEGEDLY NOT AS EFFECTIVE AS IT HAS BEEN IN THE PAST. IN ADDITION, THE PT IS SAID TO EXPERIENCE A BURNING SENSATION IN HIS HIP WHEN WALKING. THE REPORTED DISCOMFORT IS PRESENT REGARDLESS OF THE STIMULATOR'S FUNCTION. WHEN THE STIMULATION IS NOT IN USE, THE PT ALLEGEDLY CANNOT FEEL HIS LEGS. F/U ON THE PT FOUND THAT HE RECENTLY UNDERWENT REPROGRAMMING AFTER WHICH PARTIAL THERAPY RELIEF WAS OBTAINED. EFFORTS ARE UNDERWAY TO OPTIMIZE THE PT'S THERAPY COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 3133004

    Patients

    Seq Age Sex Outcome Treatment
    1