BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3940575 · Received June 18, 2014

    Report

    Report Number
    1627487-2014-08038
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 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 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 1 OF 2. REFERENCE MFR REPORT #1627487-2014-08052. IT WAS REPORTED THE PATIENT HAD INVALID IMPEDANCES WHEN SHE MET WITH AN SJM REPRESENTATIVE FOR REPROGRAMMING. PATIENT HAD A CT OF HER CHEST WHICH REVEALED LEADS HAD MIGRATED. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014. THE PATIENT'S PHYSICIAN EXPLANTED HER OLD LEADS AND ANCHOR AND REPLACED THEM WITH A DIFFERENT MODEL LEAD AND A NEW ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358194 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4242609

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other MODEL 3788, SCS IPG,| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| MODEL 1192, SCS ANCHOR,| MODEL 1192, SCS ANCHOR,