BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16 - CHANNEL RECHARGEABLE IPG

    MDR report key: 2201188 · Received July 29, 2011

    Report

    Report Number
    1627487-2011-07008
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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

    IT WAS REPORTED ON (B)(6) 2011 THAT ON (B)(6) 2011, THE PT'S STIMULATOR TURNS OFF BY ITSELF. PT STATED THAT THIS HAS BEEN HAPPENING FOR A LONG TIME. PT HAS BOTH CYCLE AND CONTINUOUS PROGRAMS. WHEN STIM TURNS OFF BY ITSELF, THE PT USES EITHER THE MAGNET OR THE PT PROGRAMMER (PP) TO TURN STIM BACK ON. IT WAS SUGGESTED THAT THE PT ONLY USE A CONTINUOUS PROGRAM, AND ONLY USE THE PP TO TURN STIM ON/OFF. FOLLOW-UP WITH THE PT FOUND THE SYSTEM IS STILL TURNING OFF BY ITSELF AND CAN BE RESTORED USING THE PROGRAMMER. THE PT IS CONSIDERING AN ALTERNATE METHOD TO CONTROL HIS PAIN. HE CONTINUES USE HIS STIMULATOR FOR SOME PAIN CONTROL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16 - CHANNEL RECHARGEABLE IPG TOTAL IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2802403

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANTED:| SCS LEAD: MODEL 3186 (2)| IMPLANTED: