BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2881084 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-13217
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 19, 2012
    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 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

    IT WAS REPORTED THE PT FELT WHAT HE DESCRIBED AS "SHOCKING" AT HIS IPG SITE. HE STATES IT ONLY OCCURS WHEN HE IS STRETCHING, MOVING AROUND, AND WHEN STIMULATION IS ON. THE PT ALSO STATED THE "SHOCKING" SUBSIDED APPROX AN HOUR AFTER DISCONTINUING THE STIMULATION. A DIAGNOSTIC TEST SHOWED NORMAL IMPEDANCES FOR ALL CONTACTS AND X-RAYS VERIFIED THE LEAD WAS FULLY INSERTED. A SJM REPRESENTATIVE REPROGRAMMED THE PT'S SCS SYSTEM; HOWEVER, IT DID NOT RESOLVE THE ISSUE. PT TO F/U WITH HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3143 14298

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788