BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4112982 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-20227
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 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 3. REFERENCE MFR REPORT# 1627487-2014-20226, 20228. IT WAS REPORTED THE PT EXPERIENCED AUTO-REDUCTION. DIAGNOSTIC DETERMINED INVALID IMPEDANCES ON TWO OF THE LEADS. X-RAYS REVEALED THE PERIPHERAL LEAD (OFF-LABEL) HAS MIGRATED. THE PT IS TO CONSULT WITH THE PHYSICIAN TO ADDRESS THE ISSUE. THE PT HAS 4 LEADS. TWO OF THEM ARE PERIPHERAL LEADS (OFF-LABEL). REST OF THE TWO ARE CERVICAL LEADS WITH THE SAME LOT NUMBER (MODEL# 3266).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574219 QUATTRODE SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3169 4342417

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS EXTENSION: MODEL 3341