BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2080252 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01352
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILAR ALLEGED EVENTS HAVE OCCASIONALLY RESULTED IN THE EXPLANT OF THE IPG. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION AND THE PT LOST STIMULATION AND LAST USED HIS CHARGER APPROXIMATELY ONE MONTH AGO. THE PATIENT'S CHARGER AND PROGRAMMER ALLEGEDLY WOULD NOT COMMUNICATE WITH THE IPG. A NEW CHARGING SYSTEM WAS SENT TO THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. ACCORDING TO THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM, THE IPG REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE 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 96907

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention