BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2875198 · Received December 13, 2012

    Report

    Report Number
    1627487-2012-15044
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 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

    DEVICE 4 OF 4. REFERENCE MFR REPORT: 1627487-2012-15041, 15042, 15043. IT WAS REPORTED THE PATIENT EXPERIENCES HEATING AT THE IPG POCKET SITE WHILE CHARGING AS WELL AS PAIN AROUND THE IPG POCKET SITE WHEN THE SYSTEM IS OFF. ADDITIONALLY, THE PATIENT EXPERIENCES PAIN IN HER BACK WHERE HER LEADS ARE LOCATED WHEN HER BACK IS PRESSED AGAINST A CHAIR. THE PATIENT IS PENDING FOLLOW UP WITH HER PHYSICIAN. 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
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3547074

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention SCS ANCHOR, MODEL 1192| IMPLANT DATE: