BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCS LEAD

    MDR report key: 5220510 · Received November 12, 2015

    Report

    Report Number
    1627487-2015-03540
    Event Type
    Injury
    Date Received
    November 12, 2015
    Date of Event
    October 21, 2015
    Report Date
    January 11, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL INFORMATION RECEIVED CLARIFIED AT THE TIME OF THE INITIAL REPORT, THE PATIENT HAD BEEN SCHEDULED FOR AN EXPLANT DATE OF (B)(6) 2015; HOWEVER, THE PATIENT'S SCS SYSTEM WAS EXPLANTED ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION. AS A RESULT, THE SCS SYSTEM WAS EXPLANTED. DEVICE INFORMATION IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750760 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other