BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE

    MDR report key: 3113032 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-04564
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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 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 1 OF 2. REF MFR REPORT: 1627487-2013-04565. THE PT RECEIVED FOUR LEADS WITH TWO DIFFERENT LOT NUMBERS. IT WAS REPORTED THE PT WAS UNABLE TO INCREASE THE STIMULATION DUE TO AUTO REDUCTION. THE SJM REP MET WITH THE PT FOR REPROGRAMMING AND DETERMINED 8 CONTACTS HAD INVALID IMPEDANCES. THE PT NO LONGER HAD STIMULATION COVERAGE. AN X-RAY WAS TAKEN AND NO ANOMALIES WERE NOTED. IT WAS REPORTED THERE WAS NO COURSE OF ACTION PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202531 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3156 3583239

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL 3788| SCS EXTENSION, MODEL 3341 (2)| SCS ANCHOR, MODEL 1192 (4)| IMPLANT DATE: