BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATRODE

    MDR report key: 2881425 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-14212
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 11, 2011
    Report Date
    November 11, 2011
    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

    REFERENCE MFR REPORTS: 1627487-2012-14209, 1627487-2012-14210 AND 1627487-2012-14211.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 172081

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPANT DATE:| SCS EXTENSION: MODEL 3342 (2)| SCS IPG: MODEL 3788| IMPLANT DATE: