BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3123567 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-15658
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    November 24, 2012
    Report Date
    April 24, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2013-15659, 1627487-2013-15660. THE PATIENT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. THE PATIENT REPORTED HE EXPERIENCED RESIDUAL TINGLING FROM THE KNEES DOWN AND ACHING IN HIS SCIATIC NERVE AFTER TURNING STIMULATION OFF CAUSING HIM TO STOP USING HIS SCS SYSTEM 4-5 MONTHS AGO. PATIENT IS NOW UNABLE TO COMMUNICATE WITH HIS IPG. ALSO, PATIENT'S IPG SITE WOULD BECOME SO WARM WHILE CHARGING, HE WOULD HAVE TO STOP CHARGING. THE PATIENT WAS SENT A REPLACEMENT LE CHARGING SYSTEM AS THE NEXT COURSE OF ACTION. ON (B)(4) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218748 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3365363

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS EXTENSION: MODEL 3341| IMPLANT:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT: