BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790835 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01671
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    August 21, 2007
    Report Date
    September 6, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. IPG FAILS TO CHARGE OR COMMUNICATE WITH A PPG WHEN TESTED UPSIDE DOWN, AS EXPECTED. IPG PASSED ALL FUNCTIONAL TESTS WHEN TESTED IN THE PROPER ORIENTATION. 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 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM CONSISTING OF TWO PERCUTANEOUS LEADS AND AN IPG ON (B)(6) 2006. THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2007 REPORTING THAT APPROXIMATELY NINE MONTHS AGO, BOTH COMMUNICATION WITH THE CHARGER AND IPG STIMULATION HAD CEASED. A REVIEW OF THE PATIENT'S MEDICAL HISTORY REVEALED THE PATIENT'S IPG HAD FLIPPED IN THE POCKET ONCE BEFORE BUT WAS REPOSITIONED NON-INVASIVELY. THE PHYSICIAN SUSPECTED THE DEVICE HAD FLIPPED AGAIN. BECAUSE THE PATIENT WAS NOT ABLE TO RECHARGE HER IPG OVER THE LAST NINE MONTHS, THE PHYSICIAN EXPLANTED AND REPLACED THE IPG ON (B)(6) 2007. NO ADDITIONAL DETAILS ARE AVAILABLE. FOLLOW-UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3716 49790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention