BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGING SYSTEM

    MDR report key: 3162394 · Received June 6, 2013

    Report

    Report Number
    1627487-2013-12779
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 PATIENT'S CHARGER SMOKES WHEN PLUGGED INTO THE WALL OUTLET. A REPLACEMENT CHARGER WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250055 CHARGING SYSTEM SCS CHARGER LGW ST. JUDE MEDICAL - NEUROMODULATION 3701 56846

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR SCS IPG, MODEL 3716| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3244| SCS EXTENSION, MODEL 3383| IMPLANT DATE: