BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3082450 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-01438
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PATIENT IS NO LONGER RECEIVING STIMULATION. SHE ATTEMPTED CHANGING PROGRAMS AND TURNED THE AMPLITUDE ALL THE WAY UP, BUT SHE DOES NOT FEEL ANY STIMULATION. THE PATIENT IS PENDING FOLLOW UP WITH AN SJM REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163401 PENTA SCS LEAD LGW ST. JUDE MEDICAL, NEUROMODULATION 3228 3546974

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SCS ANCHOR: MODEL 1194 (2)| SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE: