BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 2113713 · Received June 2, 2011

    Report

    Report Number
    1627487-2011-02706
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    March 14, 2011
    Report Date
    May 6, 2011
    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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED AN SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2011. IT WAS REPORTED, THE PT HAS BEEN EXPERIENCING EPISODES OF NAUSEA AND CONSTIPATION SINCE THE SCS SYSTEM WAS IMPLANTED. THE PT IS WORKING CLOSELY WITH HER PHYSICIAN TO TREAT THE SYMPTOMS WITH ORAL MEDICATIONS. THERE ARE NO PLANS TO EXPLANT OR REVISE THE SCS SYSTEM AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3259587

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANTED:| IMPLANTED:| IMPLANTED:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL: 1192| SCS ANCHOR: MODEL 1194