BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3010633 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-02371
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    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 2. REFERENCE MFR REPORT: 1627487-2013-02370. IT WAS REPORTED THE PATIENT FELT INEFFECTIVE STIMULATION FROM HER SCS SYSTEM. SHE REPORTED SHE PLANNED TO CONSULT WITH HER SURGEON REGARDING THE NEXT COURSE OF ACTION. IT WAS REPORTED THE PATIENT'S SYSTEM WAS TURNED OFF. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108535 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3817037

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention