BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3161457 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-02784
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ST. JUDE MEDCIAL - NEUROMODULATION
    Product Code
    GZB
    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 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. REFERENCE MFR REPORTS: 1627487-2013-02785 AND 1627487-2013-02786. IT WAS REPORTED THE PATIENT HAD HER SYSTEM REMOVED ON (B)(6) 2013. IT WAS REPORTED THE SYSTEM DID NOT PROVIDE HER WITH ADEQUATE PAIN RELIEF. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248991 QUATTRODE SCS LEAD GZB ST. JUDE MEDCIAL - NEUROMODULATION 3166 175092

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention SCS EXTENSION: MODEL 3386| SCS IPG: MDOEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3346| IMPLANT DATE:| SCS EXTENSION: MODEL 3342| IMPLANT DATE: