BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOCTRODE

    MDR report key: 4112899 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-08285
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A
    Product Code
    GZB
    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 1 OF 2. REFERENCE MFR REPORT #1627487-2014-08286. IT WAS REPORTED THE PT'S SCS LEADS HAD MIGRATED CAUSING A CHANGE IN THE STIMULATION COVERAGE. FLUOROSCOPIC IMAGES CONFIRMED THE PT'S LEADS HAD MIGRATED. ADDITIONAL INFO RECEIVED IDENTIFIED THE PT'S LEAD WAS EXPLANTED AND REPLACED. THE PT IS REPORTEDLY RECEIVING EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577060 IOCTRODE SCS LEAD GZB SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A 3186 4694980

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANTED:| SCS ANCHOR: MODEL 1192| IMPLANTED:| SCS IPG: MODEL 3789