BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3960874 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-02513
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    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 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 2 OF 2: REF MFR REPORT: 1627487-2014-02512. THE PT RECEIVED TWO MODEL 3166 LEADS FROM THE SAME LOT NUMBER. ALSO, TWO MODEL 3163 LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED, THE PT IS COMPLAINING SHE IS NOT RECEIVING EFFECTIVE STIMULATION THERAPY FROM HER SCS SYSTEM. THE PT STATED, SHE EXPERIENCES A PINCHING/PAINFUL SENSATION ON HER LEFT SIDE WHEN HER STIMULATION IS TURNED ON. A SJM REP MET WITH THE PT AND A SYSTEM DIAGNOSTICS SHOWED MULTIPLE INVALID LEAD CONTACTS. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427077 QUATTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3163 2775546

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other SCS IPG: MODEL 3716| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3341 (X2)