BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2993918 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-12277
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED THE CHARGING PADDLE BECOMES HOT WHEN CHARGING. THE PT STOPPED CHARGING BEFORE IT CAUSED DISCOMFORT OR PAIN. THE PT RECEIVED A NEW CHARGER AND THE SJM REP CONFIRMED THE CHARGER COMMUNICATES WITH THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89218 CHARGING SYSTEM SCS CHARGER LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3364561

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE:| SCS LEAD, MODEL 3280