BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2980058 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-02260
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    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 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

    DEVICE 4 OF 4. REFERENCE MFR REPORTS: 1627487-2013-02257, 02258 AND 02258. THE PT REC'D HER SCS SYSTEM FOR RSD. IT WAS REPORTED THE PT EXPERIENCED PAIN AT HER POCKET SITE, AND THE PHYSICIAN PAIN AT HER POCKET SITE, AND THE PHYSICIAN BELIEVED THE RSD MAY BE CONTRIBUTING TO THE PAIN. REPROGRAMMING PROVIDED SOME RELIEF BUT DID NOT RESOLVE THE ISSUE. IT WAS ALSO REPORTED THE PT EXPERIENCED HEATING AT HER POCKET SITE WHILE CHARGING. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. F/U INDICATED THE PT WAS BIT BY A DOG IN HER FOOT AND HER RSD CAUSED THE PAIN TO TRAVEL UP HER LEG TO THE POCKET SITE. IT WAS REPORTED THE PHYSICIAN EXPLANTED AND REPLACED ONE OF THE PT'S LEADS ON (B)(6) 2013 AND REPOSITIONED THE OTHER LEAD. THE PT REPORTED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77437 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3782262

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention