BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2903214 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-00003
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 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 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2013-00002. IT WAS REPORTED THE PT ((B)(6)) IS EXPERIENCING OVERSTIMULATION. THE REPORTED SENSATION ARE SAID TO OCCUR REGARDLESS OF THE IPG'S FUNCTION. THE PT HAS TEMPORARILY CEASED USE OF HER SCS SYSTEM DUE TO UNRELATED HEALTH ISSUES BUT CLAIMS SHE EXPERIENCES UNWANTED STIMULATION IN HER LEGS WHEN LYING ON HER BACK, LAUGHING, COUGHING OR SNEEZING. IN ADDITION, THE PT RECENTLY LOST WEIGHT AND REPORTS SORENESS AT THE IPG SITE. A REPROGRAMMING SESSION HAS BEEN SCHEDULED FOR FURTHER INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3721464

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention