BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3032530 · Received April 1, 2013

    Report

    Report Number
    1627487-2013-13468
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ST JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 2. REFERENCE MFR REPORT: 1627487-2013-13467. THE PATIENT HAS TWO LEADS FROM THE SAME LOT NUMBER. THE PATIENT REPORTED HE HAD TURNED OFF HIS STIMULATION FOR A COUPLE OF MONTHS TO RECOVER FROM A RECENT SPINAL FUSION SURGERY. THE PT REPORTED HE HAD FELT HEAT AT HIS IPG POCKET SITE WHEN HE STARTING USING HIS STIMULATION AGAIN. THE PATIENT HAD ALSO STATED THE HEATING AT HIS IPG POCKET SITE OCCURRED ANYTIME HIS STIMULATION WAS ON FOR MORE THAN 1 HOUR. A FULL LEAD DIAGNOSTIC TEST REVEALED ALL CONTACTS EXCEPT ONE HAD LOW IMPEDANCES, HOWEVER, THERE WERE NO INVALID IMPEDANCES. IT WAS NOTED THE PATIENT STILL HAD STIMULATION COVERAGE. FLUORO IMAGES REVEALED NO ANOMALIES. THE PATIENT¿S PHYSICIAN REVIEWED HIS X-RAYS AND FELT THE AREA MAY HAVE BEEN COMPROMISED DURING THE PATIENT¿S SPINAL FUSION SURGERY. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE. IT WAS ALSO NOTED THE PATIENT RECEIVED A NEW LOW ENERGY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133017 OCTRODE SCS LEAD LGW ST JUDE MEDICAL NEUROMODULATION 3186 2757588

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1195 (2)