BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3093683 · Received May 1, 2013

    Report

    Report Number
    1627487-2013-05629
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2013-05630. THE PT HAS THREE LEADS (TWO ARE FROM THE SAME LOT). IT WAS REPORTED, THE PT HAD FALLEN. OVER TIME THE PT LOST ADEQUATE COVERAGE. REPROGRAMMING WAS UNSUCCESSFUL. AN IMPEDANCE CHECK REVEALED HIGH IMPEDANCE. THE PT WILL UNDERGO X-RAYS FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190365 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3153 3244680

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention IMPLANT:| IMPLANT:| SCS ANCHORS: MODEL: 1194 (X3)| IMPLANT:| SCS EXTENSION: MODEL: 3343| SCS IPG: MODEL: 3688