BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2992475 · Received March 4, 2013

    Report

    Report Number
    1627487-2013-04264
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-04263. IT WAS REPORTED THE PT FELT A CONSTANT ITCHING ALL OVER HIS BODY. IT WAS REPORTED AN ALLERGY TEST MAY BE USED TO DETERMINE CAUSE. FOLLOW UP IDENTIFIED THE PT WAS SCHEDULED FOR THE REMOVAL OF THE TRIAL LEADS. IT WAS REPORTED THE PT HAD TAKEN BENADRYL PER THE PHYSICIAN. FURTHER FOLLOW UP FOUND THE BENADRYL HAD RESOLVED THE ITCHING. IT WAS REPORTED THE ISSUE WAS RELATED TO THE HEALING PROCESS AT THE INCISION SITE. IT WAS REPORTED THE PT RECEIVED EFFECTIVE STIMULATION DURING THE TRIAL, AND THE TRIAL LEADS WERE REMOVED AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91581 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3859860

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS ANCHOR: MODEL 1192(2)| IMPLANT DATE: