BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3032052 · Received March 26, 2013

    Report

    Report Number
    1627487-2013-12389
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 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
    AZ, 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 4. REFERENCE MFR REPORT NUMBERS: 1627487-2013-12388, 1627487-2013-12390 AND 1627487-2013-12391. IT WAS REPORTED THE PT IS EXPERIENCING BURNING SENSATION AT THE IPG POCKET SITE WHILE CHARGING. THE BURNING RADIATES TO THE OCCIPITAL NERVE. NOTE THE LEADS HAVE OCCIPITAL PLACEMENT (OFF-LABEL USE). THE PT ALSO EXPERIENCES BLISTERS ON TONGUE AND MOUTH, AND PT'S EAR IS RED. NOTE THE PT FELL OVER A YEAR AGO AND WAS TOLD THE LEADS HAD MIGRATED. A NEW CHARGER WAS SENT TO THE PT. ON 08/01/2012, 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
    123838 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3225 2768885

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS ANCHORS: MODEL 1194 (2)| IMPLANT DATE: