BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4092140 · Received September 3, 2014

    Report

    Report Number
    1627487-2014-20186
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    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
    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.

    Description of Event or Problem · 1

    DEVICE 2 OF 2 REFERENCE MFR REPORT#: 1627487-2014-20185. IT WAS REPORTED THE PATIENT'S OCCIPITAL LEADS (OFF-LABEL) HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE. THE PATIENT HAS 4 LEADS. THREE OF THEM HAVE THE SAME LOT NUMBER. IT IS UNKNOWN WHICH ONE IS RELATED TO THE ISSUE. THEREFORE, ALL OF THEM ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535450 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3149 67847

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other IMPLANT:| SCS ANCHOR: MODEL 3341 (2)| SCS IPG: MODEL 3788| IMPLANT: