BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1910282 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03590
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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

    DEVICE 2 OF 3. REFERENCE MANUFACTURER REPORTS: 1627487-2010-03589 AND 1627487-2010-03591. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2008. IT WAS REPORTED THE PATIENT WAS INVOLVED IN AN ABUSIVE MARRIAGE WHICH RESULTED IN MULTIPLE PHYSICAL ALTERCATIONS WITH HER SPOUSE. AS A RESULT, THE PATIENT'S LEAD HAS MIGRATED FROM ITS ORIGINAL IMPLANT LOCATION. IN ADDITION, THE PATIENT HAS REPORTED THAT HER SCS SYSTEM CAUSES HER PERSISTENT PAIN. SHE HAS CONTACTED HER PHYSICIAN TO REQUEST THE SYSTEM BE EXPLANTED. FOLLOW UP ON THE PATIENT FOUND THE SCS SYSTEM IS STILL IMPLANTED; HOWEVER, THE PATIENT IS CONTINUING TO WORK WITH HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 173560

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention