BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD, 3/4MM, 90 CM

    MDR report key: 2100781 · Received May 19, 2011

    Report

    Report Number
    1627487-2011-00694
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    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 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 2 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00693. THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM ON (B)(6) 2009 INCLUDING FOUR PERCUTANEOUS LEADS PLACED IN THE OCCIPITAL REGION (OFF-LABEL LOCATION) FROM TWO DIFFERENT LOTS. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION AND WAS UNABLE TO INCREASE THE AMPLITUDE FOR HIS THERAPY. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS ON ALL CONTACTS FOR ONE OF HIS LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PATIENT'S LEADS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD, 3/4MM, 90 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3149 2760246

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788| SCS LEAD EXTENSION: MODEL 3341| IMPLANT DATE: