BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2831592 · Received November 5, 2012

    Report

    Report Number
    1627487-2012-06697
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 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 2 OF 7. REFERENCE MFR. REPORT #: 1627487-2012-06696, 1627487-2012-06698, 1627487-2012-06699, 1627487-2012-0700, 1627487-2012-06701, 1627487-2012-06702, THE PATIENT HAS TWO SCS SYSTEMS. IT WAS REPORTED THE PATIENT EXPERIENCES HEATING AT ONE OF THE IPG SITES WHILE RECHARGING. IT WAS ALSO REPORTED ONE OF THE IPGS HAS FLIPPED IN THE POCKET. THE PATIENT ALSO EXPERIENCES OVERSTIMULATION. ON (B)(6) 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 3536670

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT:| SCS ANCHORS: MODEL: 1192 (2)