BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE

    MDR report key: 2940998 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-02152
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-02153. THE PATIENT RECEIVED TWO PERCUTANEOUS LEADS FROM SEPARATE LOTS AS PART OF HER SCS SYSTEM. THE PATIENT UNDERWENT A PROCEDURE FOR AN IPG REPLACEMENT (REFERENCE MFR REPORT: 1627487-2013-02151). IT WAS REPORTED AFTER THE IPG WAS REPLACED, THE SCS SYSTEM WAS TURNED ON AND INTRAOPERATIVE IMPEDANCE READINGS WERE HIGH FOR ALL LEAD CONTACTS. FOLLOW-UP IDENTIFIED THE PATIENT'S LEADS REMAIN IMPLANTED AND SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40318 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3156 3218983

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR IMPLANT:| SCS IPG: MODEL 3643