BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2861076 · Received December 4, 2012

    Report

    Report Number
    1627487-2012-03805
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    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

    THE PT RECEIVED 6 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS SCHEDULED TO HAVE HIS SCS LEAD LOCATED IN THE FRONT OF HIS LEFT EAR (OFF-LABEL USE) REPOSITIONED DUE TO THE PT NOT RECEIVING EFFECTIVE STIMULATION. F/U IDENTIFIED THE SCS LEAD HAD PULLED BACK. THE LEAD WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3169 3713576

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3386 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3166 (2)| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| SCS EXTENSION: MODEL 3346 (2)| SCS IPG: MODEL 3716| IMPLANT DATE:| SCS IPG: MODEL 3716