BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 2903037 · Received January 3, 2013

    Report

    Report Number
    1627487-2013-12034
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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

    IT WAS REPORTED THE PT EXPERIENCED PAIN AT THE LEAD INCISION SITE SINCE THE IMPLANT SURGERY. THE NEXT COURSE OF ACTION WAS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033 EXCLAIM 8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3224 2798859

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192