BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG

    MDR report key: 1623067 · Received February 24, 2010

    Report

    Report Number
    1627487-2009-00093
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    May 19, 2009
    Report Date
    May 19, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. EVAL METHOD - 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 4 MONTHS LATER THERE WAS NO COMMUNICATION WITH IPG TO THE CHARGING SYSTEM OR PROGRAMMER. ATTEMPTS AT USING A SECOND CHARGING SYSTEM AND A SECOND PROGRAMMER WERE UNSUCCESSFUL. X-RAYS VERIFIED THAT THE IPG HAD NOT FLIPPED IN THE POCKET SITE AND THAT ALL CONNECTIONS WERE INTACT. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG ON (B) (6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG IMPLANTABLE PULSE GENERATOR (IPG) LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 176448

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention