BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3223152 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-00384
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 2 OF 2. REFERENCE MFR REPORT # 1627487-2013-00383. THE PT (B)(6) WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS. IT WAS REPORTED THE PT WAS EXPERIENCING UNCOMFORTABLE STIMULATION IN THE KIDNEY AREA. DUE TO THE DISCOMFORT, THE PT REPORTEDLY DISCONTINUED USE OF THE THERAPY SYSTEM. AN X-RAY TAKEN FOR FURTHER INTERROGATION REVEALED BOTH OF THE PT'S LEADS HAD MIGRATED ONE VERTEBRAL BODY CAUDALLY. SURGICAL INTERVENTION WAS UNDERTAKEN WITH THE INTENT OF REPOSITIONING THE DEVICES. HOWEVER, DUE TO COMPLICATIONS ACCESSING THE EPIDURAL SPACE DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO EXPLANT THE PT'S THERAPY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317867 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3350655

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other IMPLANT DATE:| SCS IPG: MODEL: 3788