BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 4252669 · Received November 5, 2014

    Report

    Report Number
    1627487-2014-26935
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    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 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 4. REFERENCE MFR REPORT: 1627487-2014-26933, 26934, 26936. THE PT WAS IMPLANTED WITH A PNS SYSTEM (OFF-LABEL) THAT INCLUDES TWO LEADS (MODEL 3156) FROM THE SAME LOT. IT WAS REPORTED THE IPG IS INOPERABLE DUE THE PT NOT RECHARGING HER SYSTEM SINCE (B)(6) 2013. THE PT STOPPED USING HER PNS SYSTEM BECAUSE HER PAIN PATTERN CHANGED. IN ADDITION, THE PT IS EXPERIENCING PAIN AT THE LEAD SITE AND WOULD LIKE HER PNS SYSTEM REMOVED. FOLLOW UP INFORMATION IDENTIFIED THE PT UNDERWENT SURGICAL INTERVENTION TO REMOVE HER ENTIRE PNS SYSTEM WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710186 QUATTRODE SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3166 3932273

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other