BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3032240 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-05449
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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 NUMBER: 1627487-2013-05450. IT WAS REPORTED THE PATIENT HAD BEEN EXPERIENCING RIB STIMULATION. X-RAYS REVEALED LEAD MIGRATION. AS A RESULT, THE PATIENT'S LEADS WERE EXPLANTED AND REPLACED. THE DOCTOR ALSO ELECTIVELY EXPLANTED AND REPLACED THE PATIENT'S IPG. SURGICAL INTERVENTION RESOLVED THE PATIENT'S ISSUE. THE EXPLANTED PRODUCT WAS DISCARDED BY THE SURGICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130631 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 2870917

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention IMPLANT:| IMPLANT:| SCS ANCHORS: MODEL 1194 (X2)| EXPLANT:| SCS IPG: MODEL 3788