BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3110620 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-13724
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 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 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 2 OF 4. REFERENCE MFR. 1627487-2013-1372, 13725 AND 12726. IT WAS REPORTED, THE PT IS EXPERIENCING SIGNIFICANT DISCOMFORT AT HER IPG POCKET SITE. IT WAS ALSO REPORTED, THE PT ONLY FEELS STIMULATION IN THE THORACIC REGION ON HER RIGHT SIDE AND IT IS VERY UNCOMFORTABLE. X-RAYS REVEALED TWO OF THE PT'S LEADS HAD MIGRATED AND DIAGNOSTIC TESTS REVEALED THE OTHER LEAD HAD INVALID IMPEDANCES. THE PT STATED, SHE WANTS HER SYSTEM EXPLANTED. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208767 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3590651

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL 3341| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (3)