BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 2782093 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-03470
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 11, 2012
    Report Date
    June 4, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 PATIENT¿S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT¿S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT¿S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REFERENCE MFR. REPORTS: 1627487-2012-03468 & 1627487-2012-03469.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. THE PATIENT RECEIVED 3 SCS LEADS WITH DIFFERENT LOT NUMBERS. REFERENCE MFR REPORTS: 1627487-2012-03468, 03469. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION. THE PATIENT IS CONSIDERING HAVING THE SCS SYSTEM EXPLANTED. FOLLOW-UP IDENTIFIED THE PATIENT WENT TO THE ER FOR ¿PAIN CONTROL.¿ THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3185461

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS IPG, MODEL 3716| IMPLANT DATE: