BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2947266 · Received February 4, 2013

    Report

    Report Number
    1627487-2013-13162
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    THE PT REPORTED SHE WAS NOT RECEIVING RELIEF FROM HER SCS SYSTEM. THE PT ALSO STATED HER PAIN WAS STABLE AND HAS NOT ELEVATED SINCE HER INITIAL ISSUE WAS REPORTED. (REF MFR REPORT 203083-2012-11652). FOLLOW-UP IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46602 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3652593

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS IPG, MODEL 3788| IMPLANT DATE: