BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCS IPG

    MDR report key: 7084475 · Received December 5, 2017

    Report

    Report Number
    1627487-2017-08062
    Event Type
    Injury
    Date Received
    December 5, 2017
    Report Date
    January 3, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INFORMATION IS UNKNOWN AT THIS TIME. THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2017-08063. IT WAS REPORTED THAT THE PATIENT ((B)(6)) EXPERIENCED HEATING WHILE CHARGING. AS A RESULT, SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE. ON 8/1/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Description of Event or Problem · 1

    DEVICE 1 OF 2, REFERENCE MFR REPORT: 1627487-2017-08063. FOLLOW UP REVEALED THAT ISSUE HAS BEEN RESOLVED BY REPLACING THE PATIENT'S CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864479 SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other