BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 2971753 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-05158
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    August 5, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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

    IT WAS REPORTED THE PT BEGAN TO EXPERIENCE INADEQUATE COVERAGE TWO MONTHS AFTER BEING IMPLANTED. IT WAS ALSO REPORTED STIMULATION STOPS WHEN THE PT TURNS HER HEAD. THE PT WAS REFERRED TO A NEUROSURGEON FOR A SECOND OPINION. THE NEXT COURSE OF ACTION IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42229 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3685160

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788| SCS EXTENSION, MODEL 3383 (X2)| IMPLANT DATE: