BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2772004 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-11400
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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 INFO 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 3 OF 3. REFERENCE MFR REPORT: 1627487-2012-11398. REFERENCE MFR REPORT: 1627487-2012-11399. IT WAS REPORTED THE PT WAS NO LONGER RECEIVING STIMULATION IN THE CORRECT AREAS. IT WAS REPORTED THE PT DID NOT WANT TO MEET FOR REPROGRAMMING. F/U IDENTIFIED THE PHYSICIAN REPLACED THE SCS SYSTEM TO ADDRESS THE ISSUE. IT WAS REPORTED THE ISSUE WAS RESOLVED POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3146 3322728

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention IMPLANT:| SCS ANCHOR: MODEL 1192 (3)| IMPLANT:| SCS EXTENSION: MODEL 3341