BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2831834 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-13061
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 12, 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 EXPERIENCED SHALLOW BREATHING FOUR HOURS AFTER HIS SCS SYSTEM IMPLANT SURGERY. THE PATIENT WAS TRANSFERRED TO THE ICU DUE TO THE SHALLOW BREATHING. IT WAS ALSO REPORTED THE PATIENT WAS HAVING DIFFICULTY WALKING AND WAS TRANSFERRED TO AN INPATIENT REHABILITATION FACILITY. THE PATIENT HAD X-RAYS AND A CT SCAN, BUT NO DIAGNOSIS WAS MADE. FOLLOW-UP INDICATED THE PATIENT WAS OFF ALL IV MEDICATIONS AND BREATHING WELL ON HIS OWN. THE PATIENT WAS LEAVING THE REHABILITATION FACILITY AND GOING HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3763707

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R SCS IPG, MODEL 3788| SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE:| IMPLANT DATE: