BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2903132 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-03002
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REF MFR REPORT: 1627487-2013-03003 AND 1627487-2013-03004. THE PT RECEIVED 2 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS NOT RECEIVING STIMULATION IN HIS LEFT LEG. A SJM REP WAS UNABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING. IT WAS ALSO REPORTED THE PT'S LEFT EPIDURAL SCS LEAD HAS INVALID IMPEDANCE VALUES. ADDITIONALLY, IT WAS REPORTED THE PT IS NOW ONLY USING HIS RIGHT EPIDURAL SCS LEAD AND IS NOT USING HIS RIGHT SCS LEAD DUE TO EXPERIENCING BURNING/STINGING DURING THE PROGRAMMING SESSION. THE PT IS USING THE NEW PROGRAMS AND HIS PROGRESS IS BEING MONITORED. F/U IDENTIFIED THE ISSUES HAVE NOT BEEN RESOLVED. THE PT IS WORKING WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3110796

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS EXTENSION: MODEL 3341 (2)| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788