BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3022384 · Received March 22, 2013

    Report

    Report Number
    1627487-2013-03415
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 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 2. REFERENCE MFR. REPORT: 1627487-2013-03416. THE PT RECEIVED 2 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS EXPERIENCING A HEADACHE AFTER UNDERGOING A LEAD REVISION PROCEDURE. IT WAS ALSO REPORTED THE PHYSICIAN BELIEVES THE PT IS EXPERIENCING A SPINAL HEADACHE AND HIS ADVISED THE PT OF RECOMMENDATIONS TO RESOLVE THE ISSUE. ON (B)(6) 2013 FOLLOW-UP IDENTIFIED THE ISSUE HAS NOT RESOLVED WITH THE RECOMMENDATIONS. ON (B)(6) 2013 FOLLOW-UP IDENTIFIED THE ISSUE RESOLVED ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120258 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3879973

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCS IPG: MODEL: 3788| SCS EXTENSION: MODEL: 3341| IMPLANT DATE:| IMPLANT DATE: