BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3176752 · Received June 13, 2013

    Report

    Report Number
    1627487-2013-15799
    Event Type
    Injury
    Date Received
    June 13, 2013
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2013
    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 INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-15798. IT WAS REPORTED THE PATIENT HAD NOT USED OR CHARGED HER SCS SYSTEM IN OVER A YEAR DUE TO EXPERIENCING INEFFECTIVE STIMULATION. SUBSEQUENTLY, SHE IS UNABLE TO COMMUNICATE WITH OR CHARGE HER IPG. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE ISSUE. THE PATIENT IS CONSIDERING UNDERGOING SURGICAL INTERVENTION AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268990 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3175257

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other IMPLANT DATE:| SCS ANCHOR, MODEL 1192