BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3960674 · Received July 21, 2014

    Report

    Report Number
    1627487-2014-15554
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 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 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-15553. IT WAS REPORTED THE PT EXPERIENCES INEFFECTIVE STIMULATION. SURGICAL INTERVENTIONAL WAS UNDERTAKEN ON (B)(6) 2014 AND BOTH OF THE PATIENT'S MODEL 3146 LEADS WERE EXPLANTED AND REPLACED. ADDITIONALLY, THE PATIENT'S IPG WAS ELECTIVELY EXPLANTED AND REPLACED. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424005 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3146 3175271

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3341| IMPLANTED:| SCS LEAD: MODEL 3186| IMPLANTED:| IMPLANTED: