BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4060295 · Received August 25, 2014

    Report

    Report Number
    1627487-2014-26672
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    August 4, 2014
    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 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 IS NOT RECEIVING EFFECTIVE STIMULATION. X-RAYS WERE TAKEN AND SHOWED THE LEAD HAD MIGRATED. INITIALLY REPROGRAMMING WAS ABLE TO RESOLVE THE ISSUE. HOWEVER, THE STIMULATION ISSUE REOCCURRED. F/U INFO IDENTIFIED THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 WHERE A NEW LEAD WAS ADDED. THE PT IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515040 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3163 3847667

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other SCS ANCHOR: MODEL 1192 (2)| SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3245| IMPLANT DATE: