BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4093608 · Received September 4, 2014

    Report

    Report Number
    1627487-2014-25600
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    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 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 3. REFERENCE MFR. REPORT#: 1627487-2014-25438 AND 1627487-2014-25601.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542182 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3885700

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other IMPLANT DATE:| SCS IPG, MODEL: 3716| IMPLANT DATE:| SCS EXTENSION, MODEL: 3341| SCS ANCHOR, MODEL: 1192| IMPLANT DATE: