BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2881040 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-06928
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD FALLEN. SINCE FALLING, THE PT HAS BEEN UNABLE TO TURN STIMULATION ON DUE TO THE AMPLITUDE AUTO REDUCING. REPROGRAMMING WAS UNSUCCESSFUL. AN IMPEDANCE CHECK REVEALED HIGH IMPEDANCE ON ONE CONTACT. THE PT PLANS TO F/U WITH HER DOCTOR ABOUT THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3428645

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT:| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192| SCS EXTENSION: MODEL 3383