BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1971439 · Received January 21, 2011

    Report

    Report Number
    1627487-2011-02076
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    October 29, 2010
    Report Date
    December 28, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2009. IN (B)(6) 2010, THE PT REPORTED THAT HIS CHARGING SYSTEM HAD COME APART AND REQUESTED A REPLACEMENT SYSTEM. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT AND FOLLOW UP FOUND THAT THE REPLACEMENT SYSTEM WAS FUNCTIONING PROPERLY. IN (B)(6) 2010, THE PT PRESENTED FOR A ROUTINE FOLLOW UP APPOINTMENT. DURING THE APPOINTMENT, THE PHYSICIAN DISCOVERED THE PT DID NOT UNDERSTAND WHEN OR HOW TO RECHARGE HIS IPG. FURTHER, HE HAD NOT RECHARGED THE IPG SINCE IMPLANT. AS A RESULT, THE PT WAS NOT RECEIVING ANY STIMULATION FROM THE IPG. ATTEMPTS TO RECHARGE IN THE PHYSICIAN'S OFFICE WERE UNSUCCESSFUL. THE PHYSICIAN COULD NOT ELICIT ANY TELEMETRY FROM THE IPG DUE TO SUSPECTED BATTERY DEPLETION. AN IPG REPLACEMENT WAS RECOMMENDED BUT, HAS NOT BEEN SCHEDULED AT THIS TIME. IT IS UNK IF THE IPG WILL BE RETURNED TO THE MANUFACTURER AFTER IT IS EXPLANTED. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2783562

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention