BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3192085 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02875
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 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: 1627487-2013-02876. THE PT HAS FOUR LEADS FROM TWO SEPARATE LOTS WHICH WERE IMPLANTED FOR MIGRAINES (OFF-LABEL). IT WAS REPORTED ONE OF THE PT'S LEADS HAD HIGH IMPEDANCE READINGS, AND REPROGRAMMING WAS UNABLE TO PROVIDE ADEQUATE STIMULATION. FOLLOW-UP IDENTIFIED THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2013. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE. THE EXPLANTED DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. AS THE AFFECTED LEAD IS UNK, ALL POSSIBLE LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281067 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3149 3406153

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other SCS EXTENSION: MODEL 3346 (2)| SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE: