BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGING SYSTEM

    MDR report key: 1946135 · Received December 15, 2010

    Report

    Report Number
    1627487-2010-04027
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. WE ARE SUBMITTING THIS MDR AS THE RESULT OF A RE-EVALUATION OF OUR MDR REVIEW PROCESS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM, INCLUDING A RECHARGEABLE IPG AND EXTERNAL CHARGING SYSTEM, ON (B)(6) 2008. IT WAS REPORTED THE PT BEGAN FEELING A HEATING SENSATION EACH TIME SHE CHARGED HER DEVICE. THE PROBLEM BECAME PROGRESSIVELY WORSE UNTIL THE IPG POCKET BECAME HOT TO THE TOUCH. A NEW CHARGING SYSTEM WAS SHIPPED TO THE PT. F/U WITH THE PT FOUND THAT THE HEATING SENSATION WAS RESOLVED WITH THE USE OF THE NEW CHARGING SYSTEM. THE IPG REMAINS IN USE. THE CHARGING SYSTEM WAS RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER PT COMPLICATIONS WERE REPORTED AS RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention