BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2820111 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-06685
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    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 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. REFERENCE MFR. REPORT#: 1627487-2012-06684, REFERENCE MFR. REPORT#: 1627487-2012-06686. IT WAS REPORTED, ONE OF THE PT'S LEADS REVEALED INVALID IMPEDANCE. IT WAS ALSO REPORTED, THE OTHER 2 LEADS WERE PROVIDING THE PT WITH UNCOMFORTABLE STIMULATION. THE PT HAD NON-DEVICE RELATED HEALTH CONCERNS AND NEEDED TO UNDERGO AN MRI. AS A RESULT, THE PT'S SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3290728

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS IPG: MODEL: 3716| IMPLANT:| SCS ANCHORS: MODEL: 1192(3)| EXPLANT:| SCS EXTENSION: MODEL: 3341| EXPLANT:| IMPLANT:| IMPLANT:| EXPLANT: