BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3012157 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-13275
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    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 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 PATIENT HAS TWO LEADS FORM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT'S PERIPHERAL FIELD LEAD (OFF-LABEL) WHICH WAS PLACED IN THE LUMBAR/SACRAL AREA HAD MIGRATED AND COILED BACK TOWARDS THE PATIENT'S IPG. X-RAYS CONFIRMED THE EVENT. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106222 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3571569

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3286| SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS EXTENSION: MODEL 3341