BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 1962663 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-00068
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: 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. THE RETURNED IPG SUCCESSFULLY COMMUNICATED WITH A LAB PT PROGRAMMER AND LAB CHARGING SYSTEM. STIMULATION OUTPUT USING THE PT PROGRAM PARAMETERS WAS MONITORED IN SALINE FOR ABOUT 3 HOURS WITH NO ANOMALIES NOTED. HOWEVER, THERE WAS SOME RESISTANCE IN BOTH SEPTUM WHEN THE LEADS WERE INSERTED. THE IPG TESTED ON THE AUTO-TESTER AND FAILED THE UCOD TEST DUE TO LOOSE BALL SEAL SPRING. THE MECHANICAL RESISTANCE OBSERVED IN THE HEADER WORSENED DURING TESTING. NO FURTHER TESTING COULD BE DONE DUE TO LOOSE BALL SEAL SPRINGS. CONCLUSION - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH AN IPG AND TWO PERCUTANEOUS LEADS ON (B)(6) 2006 FOR BILATERAL LEG AND LOW BACK PAIN. IT WAS REPORTED THAT SHE HAD EXPERIENCED OVERSTIMULATION AND DIFFICULTY RECHARGING HER IPG. IN ADDITION, THE IPG HAD BECOME MORE SUPERFICIAL DUE TO HER RECENT WEIGHT LOSS. ON (B)(6) 2010, THE PT'S SJM SCS SYSTEM WAS REPLACED WITH ONE FROM A COMPETING MFR. WHEN TESTED, INTRAOPERATIVELY, THE SJM LEADS WERE SAID TO FUNCTION AS DESIGNED. THEREFORE, A PROBLEM WITH THE SJM IPG WAS SUSPECTED. THE EXPLANTED LEADS WERE DISCARDED; HOWEVER, THE IPG WAS RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 47802

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention