BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2485104 · Received March 5, 2012

    Report

    Report Number
    1627487-2012-09304
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    IT HAS BEEN REPORTED THE PT PROGRAMMER AMPLITUDE KEYS ARE NOT WORKING CONSISTENTLY. THE PT HAS STIMULATION. A REPLACEMENT PT PROGRAMMER DID NOT RESOLVE THE ISSUE. THE PT CONTINUES TO WORK WITH THE SJM REPRESENTATIVE TO DETERMINE THE NEXT STEP TO RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3463527

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3228