BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 3122322 · Received May 15, 2013

    Report

    Report Number
    1627487-2013-02659
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 1 OF 3. REFERENCE MFR REPORTS: 1627487-2013-02660 AND 1627487-2013-02661. IT WAS REPORTED THE PT HAD NOT EXPERIENCED EFFECTIVE STIMULATION COVERAGE NOR ADEQUATE PAIN RELIEF SINCE HER IMPLANT. REPROGRAMMING EFFORTS WERE UNABLE TO RESOLVE THE ISSUE. IT WAS REPORTED THE PT WILL BE REPROGRAMMED AGAIN IN APPROX ONE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214449 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3225 3736535

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention