BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATRODE

    MDR report key: 3366322 · Received September 18, 2013

    Report

    Report Number
    1627487-2013-22032
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    August 27, 2013
    Report Date
    August 27, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 3 OF 4. REFERENCE MFR. REPORTS: 1627487-2013-220229, 1627487-2013-220230, AND 1627487-2013-220231.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470758 QUATRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3169 3541251

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SCS EXTENSION: MODEL 3386| SCS EXTENSIONS: MODEL 3346 (X2)| IMPLANT:| SCS IPGS: MODEL 3716 (X2)| IMPLANT:| IMPLANT: