BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2881281 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-00820
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2012-00819. IT WAS REPORTED THE PATIENT ((B)(6)) HAS EXPERIENCED SEVERE VOMITING SINCE BEING DISCHARGED FOLLOWING HER SCS SYSTEM IMPLANT. THE PATIENT ALSO ALLEGED THE THERAPY BEING DELIVERED WAS NOT THE SAME AS IT WAS POST-OPERATIVELY. IN ADDITION, SHE CLAIMED THAT THE IMPLANT DEPTH FOR ONE OF HER LEADS WAS VERY SUPERFICIAL. EFFORTS TO ADDRESS THE STIMULATION ISSUE VIA REPROGRAMMING WERE UNSUCCESSFUL, AND IT WAS SUSPECTED THE UNCOMFORTABLE STIMULATION WAS THE RESULT OF LEAD MIGRATION. SURGICAL INTERVENTION WAS SCHEDULED WITH THE INTENT OF REVISING HER LEADS. THE PATIENT THEN ADVISED THE PHYSICIAN THAT SHE WAS EXPERIENCING STIMULATION AT THE IPG SITE. AN X-RAY WAS TAKEN FOR FURTHER INTERROGATION AND IT WAS FOUND LEAD MIGRATION HAD NOT OCCURRED. HOWEVER, THE PHYSICIAN DECIDED TO EXPLANT THE PATIENT'S SCS SYSTEM AS IT WAS SUSPECTED THE UNCOMFORTABLE SENSATION WAS DUE TO THE IPG INSERTION, AND THE PATIENT'S THIN PHYSIQUE. FOLLOW-UP ON THIS MATTER FOUND THE REPORTED VOMITING SUBSIDED FOLLOWING THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3239239

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention