BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3032245 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-03451
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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

    DEVICE 1 OF 3. REFERENCE MFR. REPORTS: 1627487-2013-03452 AND 1627487-2013-03453. IT WAS REPORTED THE PATIENT IS EXPERIENCING HEATING WHILE CHARGING HER SCS SYSTEM. SUBSEQUENTLY, A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT. FOLLOW-UP IDENTIFIED, THE REPLACEMENT CHARGING SYSTEM DID NOT RESOLVE THE ISSUE. ADDITIONALLY, THE PATIENT IS UNABLE TO FULLY CHARGE HER SCS IPG. THE PATIENT IS WORKING WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION. ON (B)(4) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131170 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3161613

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3228