BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3890908 · Received June 4, 2014

    Report

    Report Number
    1627487-2014-15441
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 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 3 OF 4. REFERENCE MFR REPORT: 1627487-2014-15439, 1627487-2014-15440, 1627487-2014-15442. THE PATIENT HAS 4 MODEL 3146 LEADS (2 FROM THE SAME LOT AND 2 FROM DIFFERENT LOTS) IMPLANTED AS PART OF HER SCS SYSTEMS. IT WAS REPORTED THE PATIENT EXPERIENCES PAIN AT THE IPG SITE REGARDLESS OF STIMULATION BEING ON OR OFF. THE PATIENT ALSO EXPERIENCES INEFFECTIVE STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014. THE IPG WAS EXPLANTED AND REPLACED AND AN ADDITIONAL LEAD WAS IMPLANTED. THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE AND THE PAIN AT THE IPG SITE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327798 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3146 14451

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other IMPLANT DATE:| MODEL 3341 (2), SCS EXTENSION