BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3042124 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-05467
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    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

    DEVICE 2 OF 2: REFERENCE MFR REPORT #: 1627487-2013-05466. THE PT HAS LEADS FOR OFF-LABEL USE. IT WAS REPORTED THE PT EXPERIENCES PAIN IN HIS NECK WHEN STIMULATION IS ON. X-RAYS WERE TAKEN AND REVEALED ONE OF THE PT'S LEADS (PLACED IN THE OCCIPITAL AREA) HAS MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138934 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3530253

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention IMPLANTED:| SCS EXTENSIONS: MODEL 3386 (X2)| IMPLANTED:| IMPLANTED:| SCS IPGS: MODEL 3716| IMPLANTED:| SCS LEAD: MODEL 3169| IMPLANTED:| SCS LEADS: MODEL 3189 (X2)| SCS LEAD: MODEL 3169| SCS EXTENSIONS: MODEL 3346 (X2)| IMPLANTED: