BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3133699 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-04619
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 29, 2013
    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 1 OF 3: REFERENCE MFR REPORT: 1627487-2013-04620. REFERENCE MFR REPORT: 1627487-2013-04621. IT WAS REPORTED THE PATIENT HAD EXPERIENCED A SHOCKING SENSATION WHICH CAUSED A DECREASE IN MOVEMENT. THE PATIENT REPORTED HER HUSBAND HAD TURNED THE SCS SYSTEM OFF USING THE MAGNET. FOLLOW UP FOUND REPROGRAMMING PROVIDED STIMULATION COVERAGE, HOWEVER, AND X-RAY REVEALED THE QUATTRODE LEADS HAD MIGRATED. IT WAS REPORTED THE PHYSICIAN HAD REFERRED THE PATIENT FOR SURGICAL INTERVENTION TO REPLACE THE LEADS WITH A SURGICAL LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222889 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3647921

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3341| IMPLANT DATE: