BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2230598 · Received August 12, 2011

    Report

    Report Number
    1627487-2011-02938
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 25, 2015
    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
    Health Professional
    N

    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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT AFTER A FALL IN (B)(6), THE PT HAD A GRADUAL LOSS OF STIMULATION. REPROGRAMMING WAS ATTEMPTED TO NO AVAIL. X-RAYS SHOWED NO VISIBLE SIGNS OF LEAD FRACTURE OR DISCONNECTION. THE PT WILL HAVE A SURGICAL REVISION. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2791010

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention IMPLANT: | SCS LEAD: MODEL: 2 X 3186| IMPLANT:| SCS LEAD: MODEL: 2 X 3186