BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3890433 · Received June 4, 2014

    Report

    Report Number
    1627487-2014-26480
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 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 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

    THE PT HAS A PNS SYSTEM (OFF LABEL) WHICH INCLUDES 4 LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT EXPERIENCED STIMULATION IN THE WRONG LOCATION. THE PT'S LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2014. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327637 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3768703

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (4)| SCS IPG, MODEL 3788| IMPLANT DATE:| SCS EXTENSION, MODEL 3341 (2)