BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATRRODE

    MDR report key: 4132711 · Received September 29, 2014

    Report

    Report Number
    1627487-2014-15703
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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 1 OF 3. REF MFR REPORT #1627487-2014-15704. REF MFR REPORT # 1627487-2014-15705. THE PT RECEIVED 2 MODEL 3066 LEADS (FROM THE SAME LOT) AS PART OF HER TRIAL SCS SYSTEM. THE PT UNDERWENT A PROCEDURE FOR A TRIAL SCS SYSTEM ON (B)(6) 2014. THE TRIAL LEADS WERE REMOVED ON (B)(6) 2014 AND AT THAT TIME THE PT INFORMED HER PHYSICIAN SHE WAS EXPERIENCING A SORE NECK. THE PT LATER EXPERIENCED A HEADACHE AND HER PHYSICIAN ADVISED HER TO GO TO THE EMERGENCY ROOM. THE PT HAD A BLOOD PATCH PERFORMED ON (B)(6) 2014 AND HER HEADACHE AND SORE NECK HAVE SINCE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604628 QUATRRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3046 4306742

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention