BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG

    MDR report key: 1623005 · Received February 24, 2010

    Report

    Report Number
    1627487-2009-00067
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    February 27, 2009
    Report Date
    February 16, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 A SIGNIFICANT DEVICE ADVERSE EVENT RESULTING IN A SURGICAL PROCEDURE TO REMOVE THE DEVICE. EVAL RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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 HER IPG ON (B) (6) 2009. IT WAS REPORTED THAT A FEW DAYS LATER THE PT WAS ABLE TO SUCCESSFULLY CHARGE HER IPG, BUT BY (B) (6) 2009 HER IPG WAS READING "LOW" AND SHE COULD NOT GET HER CHARGING UNIT TO REMAIN AT FLASHING GREEN. A FEW DAYS AFTER THAT THE PT REPORTED SHE WAS ABLE TO FIND THE IPG WITH HER PROGRAMMER, BUT THERE WAS NO COMMUNICATION BETWEEN HER IPG AND CHARGER AT ALL. FURTHER ATTEMPTS WITH AN ADDITIONAL CHARGING SYSTEM STILL WOULD NOT ESTABLISH COMMUNICATION WITH HER IPG. THE PHYSICIAN EXPLANTED HER IPG ON (B) (6) 2009 AND REPLACED IT WITH THE SAME MODEL IPG. FOLLOW-UP WITH THE PT FOUND THAT SHE IS DOING OKAY AND RECEIVING STIMULATION.

    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 176468

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention