BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2193096 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-05001
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 THEIR SCS SYS ON (B)(6) 2008. IT WAS REPORTED THAT THE PT HAD NOT CHARGED OR USED THE SYS FOR 6 MONTHS. STIMULATION WAS OFF AND REP WAS ABLE TO CHARGE PT'S SYS IN THE OFFICE. A SPACER KIT WAS SENT TO THE PT, BUT PT FEEDBACK HAS NOT BEEN RECEIVED. ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE PT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. ACCORDING TO THE MFR'S DEVICE REGISTRATION SYS, THE IPG REMAINS IMPLANTED. NO FURTHER PT 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 3716 174329

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3219