BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850306 · Received May 15, 2014

    Report

    Report Number
    1627487-2014-23320
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 23, 2014
    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-23322. THE PT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT EXPERIENCED DISCOMFORT AT THE IPG SITE. IT WAS ALSO REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION. THE PHYSICIAN ADVISED THE PT TO TURN THE DEVICE OFF FOR A WEEK OR TWO. THEREAFTER, THE PT WILL DECIDE IF SHE WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291465 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 4224781

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other IMPLANTED:| SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3383 (2)| IMPLANTED: