BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2921816 · Received January 14, 2013

    Report

    Report Number
    1627487-2013-04065
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    October 10, 2012
    Report Date
    December 26, 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
    WV, 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

    THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT WAS UNABLE TO INCREASE THE AMPLITUDE OF THE SYSTEM DUE TO AUTO-REDUCING. THE SJM MET WITH THE PATIENT FOR REPROGRAMMING BUT WAS UNABLE TO PROVIDE STIMULATION COVERAGE DUE TO MULTIPLE INVALID CONTACTS. IT WAS REPORTED THE PATIENT WAS TO HAVE AN X-RAY TAKEN. FOLLOW UP IDENTIFIED THE PHYSICIAN DETERMINED ONE OF THE LEADS WAS FRACTURED. IT WAS REPORTED SURGICAL INTERVENTION WOULD BE UNDERTAKEN AT A FUTURE DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21437 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3706758

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)