BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2930551 · Received January 24, 2013

    Report

    Report Number
    1627487-2013-13111
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 HAD IMPEDANCE ISSUES AND HER SYSTEM WAS AUTO REDUCING. A SJM REP ADJUSTED THE PT'S SCS SYSTEM; HOWEVER, IT DID NOT RESOLVE THE ISSUE. IT WAS ALSO REPORTED THE PT'S STIMULATION WAS TURNING ON AND OFF INTERMITTENTLY. FOLLOW-UP INFORMATION IDENTIFIED THE PT HAD A FALL. THE PT BELIEVES THE LOSS OF STIMULATION HAPPENED PRIOR TO THE FALL. X-RAYS IDENTIFIED THE PT HAD A PARTIALLY FRACTURED LEAD. SURGICAL INTERVENTION FOR LEAD REPLACEMENT IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34232 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3808659

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS IPG, MODEL 3788| IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE: