BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3010690 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-01293
    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
    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 3. REFERENCE MFR REPORT: 1627487-2013-1294, 1295. THE PT HAS TWO 3186 LEADS IMPLANTED WITH THE SAME LOT NUMBERS. IT WAS REPORTED THE PT IS NO LONGER RECEIVING STIMULATION IN HER CERVICAL SCS SYSTEM OR FROM HER RIGHT LUMBAR LEAD. AN SJM REP MET WITH THE PT AND LEAD DIAGNOSTICS WERE NORMAL FOR THE CERVICAL LEADS AND MULTIPLE INVALID CONTACTS ON ONE LUMBAR LEAD. THE PT FALLS ON A WEEKLY BASIS, AND DOES NOT RECALL EXACTLY WHEN SHE STOPPED FEELING THE STIMULATION. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108201 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 2875857

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| SCS IPG: MODEL 3716| SCS ANCHOR: MODEL 1192 (2)