BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD

    MDR report key: 2160723 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-02881
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    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 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 # 1627487-2011-02882. THE PT RECEIVED AN SCS SYSTEM INCLUDING TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS. IT WAS REPORTED THAT THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ONE OF HIS LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPLACE BOTH LEADS. EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3153759

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS ANCHOR: MODEL 1192| IMPLANTED:| IMPLANTED:| SCS IPG: MODEL 3788