BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1960983 · Received January 11, 2011

    Report

    Report Number
    1627487-2011-00046
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00047. THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG, TWO PERCUTANEOUS LEADS AND TWO ANCHORS. IT WAS REPORTED THAT THE PATIENT FEELS STIMULATION AFTER TURNING HER SCS SYSTEM OFF. THE REPORTED SENSATION IS PRESENT WHEN SHE LAYS DOWN AND IS SAID TO CAUSE PAIN. AN X-RAY OF THE PATIENT'S SCS SYSTEM WAS TAKEN; HOWEVER, NO VISIBLE ANOMALIES WERE OBSERVED. UPON PHYSICAL EXAMINATION OF THE PATIENT, A SMALL LUMP WAS FOUND AT THE LEAD INCISION SITE, BUT IT COULD NOT BE CONCLUSIVELY IDENTIFIED AS THE CAUSE OF THE REPORTED PAIN. FOLLOW-UP ON THE PATIENT FOUND THAT SHE RECENTLY UNDERWENT REPROGRAMMING TO PROVIDE THERAPY COVERAGE FOR HER ORIGINAL PAIN PATTERN. NO SURGICAL INTERVENTION IS PLANNED AT THIS TIME, HOWEVER, THE PATIENT'S SITUATION WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 3166006

    Patients

    Seq Age Sex Outcome Treatment
    1