BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3940490 · Received June 18, 2014

    Report

    Report Number
    1627487-2014-03435
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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. REFERENCE MFR. REPORT: 1627487-2014-03434. IT WAS REPORTED THE PATIENT IS NO LONGER RECEIVING EFFECTIVE LEFT FOOT STIMULATION. X-RAYS HAD PREVIOUSLY IDENTIFIED THE RIGHT THORACIC SCS LEAD IS FRACTURED AND DIAGNOSTICS PREVIOUSLY SHOWED INVALID IMPEDANCE VALUES; HOWEVER, EFFECTIVE STIMULATION WAS ACHIEVED THROUGH REPROGRAMMING. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358122 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3929354

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3341(2)| SCS ANCHOR: MODEL 1192(4)| IMPLANT DATE: