BEUDAMED
    FDA Adverse Event Other Summary report: N

    EON C 16-CHANNEL IPG

    MDR report key: 2163709 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-00829
    Event Type
    Other
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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 AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE PT OBSERVED THE LOW BATTERY MESSAGE ON THE PROGRAMMER. THE MESSAGE, WHICH IS BELIEVED TO BE INDICATIVE OF BATTERY PASSIVATION WAS SUCCESSFULLY CLEARED. THE PT IS WORKING CLOSELY WITH HIS PAIN PHYSICIAN TO DETERMINE IF SURGICAL INTERVENTION WILL BE REQUIRED TO REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON C 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 2751606

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS LEAD ANCHOR: MODEL 1192| IMPLANT:| SCS LEADS: MODEL 3186| IMPLANT: