BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2820147 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-06677
    Event Type
    Injury
    Date Received
    November 2, 2012
    Report Date
    October 8, 2012
    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 2 OF 3. REF MFR REPORT # 1627487-2012-06676. REF MFR REPORT # 1627487-2012-06678. IT WAS REPORTED THE PT HAS FALLEN ON SEVERAL OCCASIONS IN THE PAST. IT WAS ALSO REPORTED THE PT IS EXPERIENCING STOMACH STIMULATION. ONE OF THE PT'S LEADS IS ALSO CAUSING DISCOMFORT. AN IMPEDANCE CHECK REVEALED NO ANOMALIES. THE PT PLANS TO UNDERGO SURGICAL INTERVENTION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 57007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT:| SCS IPG: MODEL 3716| IMPLANT:| SCS EXTENSION: MODEL 3341