BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3821039 · Received May 7, 2014

    Report

    Report Number
    1627487-2014-25351
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 1 OF 2. REFERENCE MFR REPORT NUMBER: 1627487-2014-25352. THE PT HAS TWO SCS SYSTEMS. THE EVENT IS RELATED TO THE SYSTEM IMPLANTED ON (B)(6) 2014. IT WAS REPORTED THE PHYSICIAN ATTEMPTED TO REMOVE THE PATIENT'S STAPLES FROM THEIR LEAD INCISION SITE AND THE WOUND OPENED UP. IN TURN, THE PHYSICIAN DECIDED TO LEAVE THE STAPLES IN PLACE AND ATTEMPT TO REMOVE THEM AGAIN AT A LATER DATE. FOLLOW-UP REVEALED THE PATIENT'S WOUND HAS FULLY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276838 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL NEUROMODULATION 3163 4061204

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: