BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2792265 · Received October 10, 2012

    Report

    Report Number
    1627487-2012-01832
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 11, 2011
    Report Date
    September 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-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 WAS 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, THE PT IS EXPERIENCING A SHARP, STABBING, JOLTING PAIN AT HIS IPG SITE SINCE IMPLANT. IN THE PAST YEAR, IT HAS PROGRESSIVELY GOTTEN WORSE CAUSING HIM TO GO TO THE EMERGENCY ROOM. HE REPORTS TROUBLE SLEEPING, AND UNABLE TO LAY ON HIS LEFT SIDE AND HAS LOST WEIGHT. THE PT SUFFERS FROM RSD IN HIS LOWER BACK AND RIGHT HIP, AND PROGRESSING INTO BLE. HIS PHYSICIAN STATED, THE RSD IS NOT RELATED TO THIS SCS SYSTEM, BUT IS RELATED TO HIS PREVIOUS 4 BACK SURGERIES. HIS PHYSICIAN STATED, THE RSD HAS PROGRESSED INTO THE PT'S IPG POCKET. THE PHYSICIAN GAVE THE OPTION OF REMOVING THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3371472

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention IMPLANT:| SCS ANCHOR: MODEL 1194 (2)| SCS LEAD: MODEL 3228| IMPLANT: