BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2892377 · Received December 27, 2012

    Report

    Report Number
    1627487-2012-15125
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    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 PATIENT'S CHARGING ANTENNA GETS HOT WHILE SHE CHARGES. THE PATIENT WAS ASKED IF HEATING WAS FELT AS THE IPG POCKET SITE AND THE PATIENT INDICATED THE HEATING WAS ONLY FROM THE EXTERNAL DEVICE. THE PATIENT WAS SENT A REPLACEMENT CHARGER. FOLLOW-UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3239130

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS IPG: MODEL 3778| IMPLANT DATE:| SCS LEAD: MODEL 3228| IMPLANT DATE: