BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 1962668 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-01050
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 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
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE RECEIVED. RESULTS - REVIEW OF THE DEVICE HISTORY RECORDS FOUND SEVERAL NONCONFORMANCES; HOWEVER, PRODUCT WAS REWORKED AND APPROVED FOR USE. THE DHR ANOMALIES ARE NOT RELATED TO THE ALLEGED DEVICE FAILURE. A CUT WAS OBSERVED ON THE HEADER AND ANTENNA COVER, AND THE HEADER CUT WAS OBSERVED AS GOING THROUGH TO THE BALL SEAL RINGS. THIS CUT WAS CONSIDERED CONSISTENT WITH EXPLANT DAMAGE. THE IPG FAILED THE UNIVERSAL CONNECTIVITY OUTPUT DEVICE TEST; THE FAILURE WAS THOUGHT TO BE CONSISTENT WITH THE EXPLANT DAMAGE NOTED ON THE SILICONE HEADER. THE IPG PASSED COMMUNICATION WITH THE LAB PROGRAMMER. 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

    REFERENCE MFR REPORT: 1627487-2011-01051. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS, ON (B)(6) 2005. IT WAS REPORTED THAT THE PT HAD A TRACTOR ACCIDENT AND HAD DIFFICULTY CHARGING HIS IPG AFTER THIS INCIDENT. THE PT WAS SCHEDULED FOR A LEAD REVISION PROCEDURE (REFERENCE MFR REPORT: 1627487-2011-01051), AND THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE IPG AS WELL. THE EXPLANTED IPG WAS RETURNED TO THE MFR FOR ANALYSIS. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 36710A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention