BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG

    MDR report key: 1623086 · Received February 24, 2010

    Report

    Report Number
    1627487-2009-00096
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    August 25, 2009
    Report Date
    August 25, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    "MALFUNCTION" IS INTERPRETED AS A COMPROMISE OF THE DEVICE'S THERAPEUTIC EFFECTIVENESS (LOSS OF PAIN RELIEF) WHICH CONTRIBUTED TO SIGNIFICANT DEVICE ADVERSE EVENT RESULTING IN A SURGICAL PROCEDURE TO REMOVE THE DEVICE. EVALUATION: 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. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. 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 IPG ON (B) (6) 2009. IT WAS REPORTED THAT ABOUT A MONTH POSTOPERATIVELY, THE IPG WOULD NOT HOLD A CHARGE FOR MORE THAN ABOUT 24 HOURS. PT ALSO WAS REPORTED TO HAVE DEVELOPED (B) (6) INFECTION POST-OPERATIVELY AND WAS TREATED WITH ANTIBIOTICS. THE PHYSICIAN EXPLANTED BUT DID NOT REPLACE THE IPG ON (B) (6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 2796044

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention