BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG

    MDR report key: 1623014 · Received February 24, 2010

    Report

    Report Number
    1627487-2009-00063
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    December 18, 2008
    Report Date
    December 22, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF REPORTABLE EVENT: "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 A 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 WAS IMPLANTED WITH HER IPG ON (B) (6) 2008. IT WAS REPORTED THAT THE PT'S IPG LATER CEASED COMMUNICATING WITH HER PROGRAMMER OR CHARGER. ATTEMPTS TO COMMUNICATE WITH HER IPG USING ADDITIONAL PROGRAMMERS AND CHARGERS WERE UNSUCCESSFUL. THE PHYSICIAN VERIFIED THAT THE IMPLANT DEPTH WAS CORRECT AND THAT THE IPG HAD NOT FLIPPED IN THE IMPLANT POCKET. THE PT'S LEADS WERE CHECKED AND THEY WERE FUNCTIONING PROPERLY. THE PHYSICIAN EXPLANTED THE IPG ON (B) (6) 2008 AND REPLACED IT WITH THE SAME MODEL IPG. THERE WERE NO PROBLEMS REPORTED WITH THE NEW IPG INTRAOPERATIVELY OR POSTOPERATIVELY. FOLLOW-UP WITH THE PT FOUND THAT SHE WAS RECEIVING STIMULATION AND DOING OKAY.

    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 172238

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention