BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2160613 · Received July 6, 2011

    Report

    Report Number
    1627487-2011-03216
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT HAS DIFFICULTIES CHARGING THE IPG AND HAD LOST STIMULATION FOR TWO WEEKS NOW. THE CHARGER DID NOT FUNCTION WELL AND WAS RANDOMLY BEEPING. A REPLACEMENT WAS SHIPPED TO RECTIFY THE ISSUE. NO FURTHER INFORMATION 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 3083982

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS LEAD: MODEL 3169 (2)| IMPLANTED:| SCS EXTENSION: MODEL 3341 (2)| IMPLANTED:| SCS ANCHOR: MODEL 1192| IMPLANTED:| SCS LEAD: MODEL 3169 (2)| IMPLANTED: