BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3950140 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-21431
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-21430. IT WAS REPORTED THE PT EXPERIENCED OVER-STIMULATION DOWN HER RIGHT LEG AFTER TWO WEEKS OF LIFTING. DIAGNOSTICS REVEALED INVALID IMPEDANCES ON ONE OF THE PT'S LEADS. X-RAYS DID NOT REVEAL ANY ANOMALIES. SURGICAL INTERVENTION WILL TAKE PLACE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376539 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3817704

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL 3788| SCS ANCHOR, MODEL 1192 (2)