BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2792034 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-02494
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-02493. THE PT RECEIVED TWO LEADS AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PT COULD NOT INCREASE THE AMPLITUDE OF HIS STIMULATION AS IT WAS AUTO-REDUCING. DIAGNOSTIC TESTING EXHIBITED INVALID IMPEDANCE READINGS. AN X-RAY REVEALED A KINK IN ONE LEAD AT THE ANCHOR SITE AND THE OTHER LEAD HAD MIGRATED. THE PHYSICIAN EXPLANTED AND REPLACED BOTH OF THE PT'S LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3186 3523753

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788