BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4201966 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-26863
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 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

    (B)(4). SJM HAS LIMITED INFORMATION 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

    DEVICE #1 OF 3. REFERENCE MFR. REPORT: 1627487-2014-26864, 1627487-2014-26865. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AND ONE OF THE LEADS HAD MIGRATED DOWNWARD AND CONFIRMED BY X-RAY. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REMOVE AND REPLACE THE LEADS WITH A DIFFERENT MODEL. THE PATIENT IS NOW RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663307 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3163 3778409

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3343