BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1904102 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-01643
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    March 11, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS 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. (B)(4). ANS HAS LIMITED INFO 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HIS SCS SYS ON (B)(6) 2009. IN ANTICIPATION OF AN UPCOMING HEART RESYNCHRONIZATION PROCEDURE, THE PT REPORTEDLY TURNED HIS SCS SYS OFF. DURING THE PT'S CARDIAC RESYNCHRONIZATION PROCEDURE, THE PHYSICIAN DEFIBRILLATED THE PT THREE TIMES USING EXTERNAL DEFIBRILLATION. AFTER THE PROCEDURE, THE PT REPORTED FEELING A TINGLING SENSATION ALL OVER HIS BODY. THE PT WAS ADMITTED TO THE FACILITY OVERNIGHT. ADDITIONAL INFO OBTAINED DURING F/U WITH THE PT'S FACILITY REVEALED THE PT REPORTED THE TINGLING SENSATION HAD SUBSIDED BY THE NEXT DAY; THE PT WAS DISCHARGED WITH THE SCS SYS INTACT, BUT TURNED OFF. THE SCS SYS REMAINED TURNED OFF UNTIL THE PT MET WITH HIS PAIN PHYSICIAN. EXAMINATION OF THE PT'S SCS SYS BY THE PT'S PAIN PHYSICIAN REVEALED THE IPG NEEDED TO BE REVISED. A REVISION WAS SCHEDULED. F/U ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE IPG WAS NOT RETURNED TO ANS FOR EVAL. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3788 2834656

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R