BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4132665 · Received September 24, 2014

    Report

    Report Number
    1627487-2014-03633
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    August 29, 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 2 OF 3. REFERENCE MFR. REPORTS: 1627487-2014-03632 03634 INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY, INDICATED THE PATIENT ALLEGES THE FOLLOWING ISSUES: IT WAS REPORTED THE PATIENT EXPERIENCED BURNING/HEATING AT THE SCS IPG POCKET SITE WHILE CHARGING AND OVERSTIMULATION. ADDITIONALLY, A LEGAL PRESERVATION NOTICE IDENTIFIED THE PATIENT'S SCS SYSTEM WAS EXPLANTED. ADDITIONAL INFORMATION IS NEEDED TO CLARIFY THE NATURE OF THE PATIENT'S ISSUES. SJM WAS MADE AWARE OF THE ISSUES ON (B)(6) 2014, AND THE PATIENT'S SCS SYSTEM WAS NOT EVALUATED BY AN SJM REPRESENTATIVE TO VERIFY AND/OR TROUBLESHOOT ANY OF THE ADDITIONAL REPORTED ISSUES PRIOR TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595989 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3170310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other