BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2800856 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-13007
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    July 11, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    IT WAS REPORTED, THE PATIENT HAD TROUBLE WITH STIMULATION ON HIS LEFT SIDE. DIAGNOSTIC TESTS CONFIRMED THAT THE LEAD IS IN THE CORRECT PLACE AND HAS NOT MIGRATED. SJM REPRESENTATIVE ATTEMPTED PROGRAMMING THE LEFT SIDE WITHOUT SUCCESS. SJM REPRESENTATIVE WILL DISCUSS AVAILABLE OPTIONS WITH PATIENT AND DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3655960

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: