BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC ADAPTER

    MDR report key: 3152597 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-05791
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 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
    WI, 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 AC ADAPTOR GETS VERY HOT AND IT IS NOT PERFORMING PROPERLY. AS A RESULT, THE PATIENT WAS SENT A REPLACEMENT AC ADAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247864 AC ADAPTER SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3713 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANT:| IMPLANT:| SCS IPG: MODEL 3788| SCS LEADS, MODEL: 3186 (X2)