BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3810745 · Received April 28, 2014

    Report

    Report Number
    1627487-2014-03295
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ST. JUDE MEDICAL-NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    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 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 2 OF 2. REFERENCE MFR. REPORT: 1627487-2014-03294. THE PT HAS 2 OCCIPITAL SCS LEADS (OFF-LABEL) AND 2 SUPRA-ORBITAL SCS LEADS (OFF-LABEL). THIS ISSUE IS RELATED TO THE ONE OF THE OCCIPITAL SCS LEADS. IT WAS REPORTED THE PT IS EXPERIENCING INEFFECTIVE STIMULATION. DIAGNOSTICS REVEALED INVALID IMPEDANCE VALUES FOR THE RIGHT OCCIPITAL SCS LEAD (UNKNOWN WHICH LOT #). IT WAS ALSO REPORTED X-RAYS IDENTIFIED A BREAK IN THE SCS LEAD NEAR THE NECK INCISION. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253673 QUATTRODE SCS LEAD GZF ST. JUDE MEDICAL-NEUROMODULATION 3166 4352341

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other SCS IPG: MODEL 3788| IMPLANT DATE:| SCS EXTENSION: MODEL 3343 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3169