BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2843412 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-02675
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    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 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 3 OF 3. REFERENCE MFR REPORTS: 1627487-2012-02673 AND 1627487-2012-02674. THE PATIENT HAS 2 SCS SYSTEMS. IT WAS REPORTED THE PATIENT UNDERWENT SURGERY TO ADD A NEW LEAD DUE TO NEW PAIN SHE WAS EXPERIENCING. DURING THE PROCEDURE, ONE OF THE LEADS ALLEGEDLY SLID OUT OF THE ANCHOR. THE PHYSICIAN DECIDED TO EXPLANT THE LEAD AND REPLACED IT WITH TWO NEW LEADS. HE ALSO ELECTED TO REPLACE THE PATIENT'S IPG WITH A SMALLER MODEL. IT WAS REPORTED THAT ONLY ONE PERCUTANEOUS LEAD WAS CONNECTED TO THE EXPLANTED IPG. THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM SHOWED THREE LEADS WERE PART OF THE PATIENT'S SYSTEM. ALL THREE LEADS ARE BEING REPORTED AS IT IS CURRENTLY UNDETERMINED WHICH LEAD WAS THE AFFECTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2768860

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SCS IPG, MODEL 3688| IMPLANT DATE:| SCS ANCHOR, MODEL: 1194 (2)| IMPLANT DATE:| SCS IPG, MODEL: 3788| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL: 3186 (2)