BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 2871498 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-14120
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    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 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

    IT WAS REPORTED THE PT WAS NOT RECEIVING STIMULATION. AN SJM REP MET WITH THE PT AND OBSERVED HIGH IMPEDANCE ON HER LEAD. THE PT'S LEAD WAS REPLACED WITH A NEW ONE AND THE PT HAD EFFECTIVE STIMULATION AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3225 2815241

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3262| SCS IPG: MODEL 3788| IMPLANT DATE: