BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3010673 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-01288
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 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 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-1289. IT WAS REPORTED THE PT IS UNABLE TO FEEL STIMULATION. AN SJM REPRESENTATIVE MET WITH THE PT AND LEAD DIAGNOSTICS SHOWED LOW IMPEDANCES ON ONE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108169 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3296507

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)