BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3052217 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-04415
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 14, 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

    IT WAS REPORTED THE PT WAS EXPERIENCING SHARP STIMULATION SENSATIONS. THE SJM REP MET WITH THE PT AND DETERMINED ONE CONTACT ON THE LEAD HAD A HIGH IMPEDANCE. REPROGRAMMING WAS ABLE TO RESOLVE THE SHARP FEELING, BUT WAS UNABLE TO PROVIDE FULL STIMULATION COVERAGE. X-RAYS WERE TAKEN BUT DID NOT REVEAL MIGRATION. FOLLOW UP IDENTIFIED THE PT HAD THREE INVALID CONTACTS, AND THEN LATER ALL CONTACTS WERE INVALID. THE SYS WAS AUTO-REDUCING AT PERCEPTION. IT WAS REPORTED THE PHYSICIAN PLANNED TO UNDERTAKE SURGICAL INTERVENTION AT A FUTURE DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139536 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3858971

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192| IMPLANT DATE: