BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2940651 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-00067
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 9, 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
    GM
    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

    IT WAS REPORTED THE PT'S ((B)(6)) LEADS WERE EXPLANTED. PRIOR TO THE EXPLANT PROCEDURE, THE PT HAD REPORTEDLY SUFFERED A FALL. A DIAGNOSTIC TEST TAKEN SHORTLY THEREAFTER REVEALED IMPEDANCE ISSUES FOR SEVERAL LEAD CONTACTS; HOWEVER, EFFECTIVE STIMULATION WAS CAPTURED AT THAT TIME THROUGH REPROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40972 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3649273

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SCS IPG, MODEL UNK| IMPLANT DATE:| IMPLANT DATE: UNK| SCS EXTENSION, MODEL 3383 (2)