BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16 - CHANNEL RECHARGEABLE IPG

    MDR report key: 2260251 · Received August 25, 2011

    Report

    Report Number
    1627487-2011-07125
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-07131. THE PT REC'D A SCS SYS ON (B)(6) 2010. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT HAS BEEN FEELING UNSTEADY ON HER FEET LATELY AND HAS FALLEN. THE PT WAS INSTRUCTED BY HER DOCTOR TO TURN THE STIMULATION OFF FOR ONE DAY AND SEE IF THE UNSTEADINESS PERSISTS. THE PT STATED THAT TURNING OFF HER BATTERY MADE VERY LITTLE DIFFERENCE. FOLLOW UP FOUND THAT THE PT HAS HAD A NERVE CONDUCTION STUDY (NCV) DONE SINCE CALLING TO REPORT THE ISSUE. PT STATED THAT SHE WILL DISCUSS THE RESULTS OF THE NCV AND OPTIONS REGARDING THE NEXT COURSE OF ACTION AT HER FOLLOW-UP APPOINTMENT WITH HER DOCTOR. 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 TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3170767

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention