BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 1940590 · Received December 21, 2010

    Report

    Report Number
    1627487-2010-03853
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2006. IT WAS REPORTED THAT THE PATIENT COULD NOT TURN STIMULATION UP TO PERCEPTION. A DIAGNOSTIC TEST REVEALED HIGH IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. FOLLOW UP ON THE PATIENT FOUND THAT AN X-RAY DID NOT SHOW LEAD MIGRATION OR FRACTURE. THE PATIENT WAS REPROGRAMMED AND REPORTED ADEQUATE STIMULATION COVERAGE. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILAR REPORTED EVENTS HAVE RESULTED IN THE EXPLANT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL- NEUROMODULATION DIVISION 3716 56030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention