BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4252694 · Received November 5, 2014

    Report

    Report Number
    1627487-2014-26931
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 #3 OF 4: REFERENCE MFR REPORT: 1627487-2014-26929, 26930, 26932. THE PT IS IMPLANTED WITH A PNS (OFF-LABEL) SYSTEM WHICH INCLUDES TWO LEADS (MODEL 3149) FROM THE SAME LOT. IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION. LEAD DIAGNOSTICS SHOWED HIGH IMPEDANCES. REPROGRAMMING WAS ABLE TO PROVIDE EFFECTIVE STIMULATION, HOWEVER; WHEN EFFECTIVE STIMULATION WAS PROVIDED FOR THE LEFT SIDE PAIN THE LEFT SHOULDER WOULD FLINCH AND THE AMPLITUDE WOULD NEED TO BE LOWERED WHICH RENDERED STIMULATION INEFFECTIVE. AN X-RAY WAS TAKEN AND RESULTS ARE PENDING. THE NEXT COURSE OF ACTION HAS NOT BEEN DISCLOSED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709963 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3169 3452806

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS EXTENSIONS: MODEL 3341(2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192(5)