BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3193629 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-15843
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 3, 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 2. REFERENCE MFR REPORT: 1627487-2013-15844. IT WAS REPORTED, THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING AND UPON INTERROGATING THE SCS SYSTEM, ONE OF THE LEADS SHOWED INVALID IMPEDANCES. ADDITIONALLY, ONE LEAD HAD MIGRATED. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUES. ALSO, THE PATIENT'S IPG WILL BE ELECTIVELY REPLACED DUE TO THE LENGTH OF TIME IT HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287529 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 A12205

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other IMPLANT:| SCS EXTENSION: MODEL 3341| IMPLANT:| SCS IPG: MODEL 3716