BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEADS

    MDR report key: 2210424 · Received August 9, 2011

    Report

    Report Number
    1627487-2011-08022
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    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 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 2 OF 3. REF MFR REPORT: 1627487-2011-08021 AND 1627487-2011-08023. IT WAS REPORTED THAT THE PT HAD INEFFECTIVE THERAPY. HE DID NOT FEEL STIMULATION AT THE PAIN LOCATION AND FELT STIMULATION IN HIS LEGS, STOMACH, AND SIDE. IT WAS REPORTED THE PT MIGHT BE RECEIVING LIGAMENT STIMULATION. INCREASED STIMULATION DID NOT RESOLVE THE ISSUE. THE ENTIRE SYSTEM WAS EXPLANTED, AND THE PHYSICIAN ALSO WANTED TO PERFORM AN MRI ON THE PT. THE PRODUCT IS NOT RETURNING TO THE MFR AS THE HOSP RETAINED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEADS SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 175436

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: 1194 (2)| SCS IPG: 3788| IMPLANT DATE: