BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2844476 · Received November 16, 2012

    Report

    Report Number
    1627487-2012-02687
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 26, 2011
    Report Date
    October 26, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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: 1627487-2012-02688. THE PT RECEIVED TWO LEADS IN HIS THORACIC REGION FOR PAIN IN THE LOW BACK AND LEGS. IT WAS REPORTED, THE PT HAD EXPERIENCED STIMULATION IN HIS RIBS OCCASIONALLY OVER THE PAST YEAR. HE WAS SUCCESSFULLY REPROGRAMMED MULTIPLE TIMES. IT WAS REPORTED, THE PT RECENTLY FELT STIMULATION IN HIS STOMACH AND X-RAYS SHOWED BOTH OF THE PT'S LEADS HAD MIGRATED. THE PHYSICIAN PLANS TO REPLACE THE LEADS WITH A PADDLE LEAD. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 2757588

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS IPG: MODEL 3788| IMPLANTED: