BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2140945 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-03141
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT 1627487-2011-03140. THE PT RECEIVED A SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2006. THE PT REPORTED THAT SHE DID NOT FEEL STIMULATION. WHEN SHE TRIED TO INCREASE THE AMPLITUDE, SHE ALLEGEDLY DID NOT GET PAST PERCEPTION LEVELS. SHE STATED SHE HAD LOST (B)(6). IT WAS REPORTED THAT HER IPG POCKET ALSO FELT LOOSE. ON (B)(6) 2011, THE PT REPORTED SHE HAD TO GO TO THE EMERGENCY ROOM BECAUSE SHE FELT JOLTS FROM HER BACK TO CHEST WHEN THE STIMULATION WAS COMPLETELY TURNED OFF. THE PT WILL FOLLOW UP WITH HER PHYSICIAN REGARDING THE ISSUES. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 46712A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention