BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD

    MDR report key: 2160729 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-02878
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 10, 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 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 # 1627487-2011-02879. THE PT RECEIVED HIS SCS SYSTEM INCLUDING FOUR PERCUTANEOUS LEADS FROM TWO LOTS ON (B)(6) 2010. IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED ON (B)(6) 2011 DUE TO INABILITY TO ACHIEVE THE STIMULATION PATTERN NECESSARY FOR PAIN RELIEF. FURTHER INTERROGATION REVEALED INVALID IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS. IN ADDITION, TWO OF THE LEADS WERE SHOWN TO HAVE PULLED OUT OF THE HEADER. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3116240

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS IPG: MODEL 3688| IMPLANT:| IMPLANT:| IMPLANT:| SCS LEAD ANCHOR: MODEL 1192| SCS EXTENSION: MODEL 3341