BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2940697 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-02160
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 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 REPORTS: 1627487-2013-02161 AND 02162. IT WAS REPORTED THE PT NO LONGER FELT EFFECTIVE BLADDER STIMULATION. REPROGRAMMING EFFORTS HAVE BEEN UNSUCCESSFUL AT RESOLVING THE ISSUE. IT WAS REPORTED THE PHYSICIAN ORDERED A FLUOROSCOPY TO EVALUATE THE LEADS AND DISCUSS TREATMENT OPTIONS. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40689 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3757221

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3342| SCS IPG: MODEL 3716