BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2833654 · Received November 12, 2012

    Report

    Report Number
    1627487-2012-11674
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 3 OF 4. REFERENCE MFR REPORT: 1627487-2012-11672, REFERENCE MFR REPORT: 1627487-2012-11673, REFERENCE MFR REPORT: 1627487-2012-11675. IT WAS REPORTED, THE PT NO LONGER HAD STIMULATION AND WAS UNABLE TO COMMUNICATE WITH THE IPG USING THE EXTERNAL DEVICES. THE SJM REP MET WITH THE PT AND CONFIRMED THE ISSUE. IT WAS ALSO REPORTED, THE PT HAD NOT RECEIVED EFFECTIVE STIMULATION IN THE PAST. F/U IDENTIFIED THE PHYSICIAN REPLACED THE IPG. IT WAS REPORTED, THE PHYSICIAN HAD TO FORCIBLY PULL ONE LEAD OUT OF THE HEADER OF THE IPG. DURING THE REMOVAL, A PIECE OF THE TIP OF EITHER THE EXTENSION OR ONE OF THE LEADS BROKE OFF INTO THE HEADER OF THE OLD IPG. THE PHYSICIAN ATTACHED THE EXISTING DEVICES INTO THE NEW IPG. WHEN THE PT WAS PROGRAMMED, IT WAS DETERMINED ONE OF THE LEADS WAS NOT ABLE TO BE USED DUE TO INVALID CONTACTS. USING THE OTHER LEAD, IT WAS REPORTED THE PT RECEIVED STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 83848

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention