BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4143100 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-26777
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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 AN 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 2. REFERENCE MFR REPORT: 1627487-2014-26778. THE MANUFACTURER IS UNABLE TO DETERMINE WHICH LEAD IS IMPLANTED ON THE RIGHT SIDE SO WE WILL REPORT ON EACH LEAD. IT WAS REPORTED THE PATIENT HAS NOT USED HER STIMULATION FOR TWO MONTHS. LEAD DIAGNOSTICS REVEALED HIGH IMPEDANCE ON THE LEAD AND ITS INABILITY TO INCREASE STIMULATION. THE LEFT LEAD SHOWS NO ANOMALIES AND IS PROVIDING EFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591281 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3153 3788261

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other SCS EXTENSION: MODEL 3343| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| SCS IPG: MODEL 3688| IMPLANT DATE:| IMPLANT DATE: