BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4180025 · Received October 15, 2014

    Report

    Report Number
    1627487-2014-23685
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    November 15, 2013
    Report Date
    September 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2014-23689. THE PATIENT HAD FOUR 3186 LEADS (TWO FROM EACH LOT) IMPLANTED AS PART OF HER SCS SYSTEM. THE PATIENT REPORTED SHE DID NOT RECEIVE EFFECTIVE PAIN RELIEF FROM HER SCS SYSTEM. THE PATIENT ALSO REPORTED SHE FELT OVERSTIMULATION AND GETTING HEADACHES FROM THE SYSTEM. THE PATIENT HAD TWO SYSTEMS AND IT IS UNKNOWN WHICH SYSTEM THE PATIENT HAD ISSUES WITH. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE HER SCS SYSTEM WAS REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654081 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 68281

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other SCS IPG: MODEL 3716| IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE: