BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3820867 · Received May 13, 2014

    Report

    Report Number
    1627487-2014-15363
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZF
    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 PATIENT HAS 4 PNS (OFF-LABEL) LEADS (FROM THE SAME LOT) IMPLANTED. THE SJM REPRESENTATIVE WAS INFORMED ON (B)(4) 2014 THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 BECAUSE 2 OF THE PATIENT'S LEADS HAD BECOME SUPERFICIAL. THE PHYSICIAN BURIED THE LEADS DEEPER. THE PATIENT REPORTS SHE HAS EFFECTIVE STIMULATION AND THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287163 QUATTRODE SCS LEAD GZF ST. JUDE MEDICAL ¿ NEUROMODULATION 3166 4155048

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other SCS EXTENSION: MODEL 3346 (2)| IMPLANT:| SCS IPG: MODEL 3788| IMPLANT: