BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 4132691 · Received September 24, 2014

    Report

    Report Number
    1627487-2014-03635
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    July 25, 2013
    Report Date
    September 3, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REPORTED THE CHARGER BOX WAS HEATING WHILE CHARGING. A REPLACEMENT (3726) CHARGING SYSTEM WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593636 CHARGING SYSTEM SCS CHARGING SYSTEM GZB ST. JUDE MEDICAL - NEUROMODULATION 3711 3814032

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE:| SCS LEAD: MODEL 3186| SCS LEAD: MODEL 3163| SCS LEAD: MODEL 3166| SCS EXTENSION: MODEL 3341| IMPLANT DATE: