BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3010520 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-04333
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 22, 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
    TX, 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 3 OF 3. REFERENCE MFR. REPORTS: 1627487-2013-04331 AND 1627487-2013-04332. IT WAS REPORTED THE PT WAS UNABLE TO COMMUNICATE WITH THE IPG USING EXTERNAL DEVICES. A REPLACEMENT PROGRAMMER AND CHARGING SYSTEM WERE SENT TO THE PT. FOLLOW UP IDENTIFIED THE REPLACEMENT DEVICES WOULD NOT COMMUNICATE WITH THE IPG. THE PHYSICIAN OPTED TO REPLACE THE IPG AND THE LEADS. IT WAS REPORTED THE LEADS WERE REPLACED BECAUSE THE STIMULATION COVERAGE IN HIS BACK HAD BECOME DIFFICULT TO MAINTAIN. FOLLOW UP IDENTIFIED THE PT REC'D EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108550 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3269066

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: