BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2832026 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-06719
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 1 OF 2. REFERENCE MFR REPORT#: 1627487-2012-06720. IT WAS REPORTED THE PT HAD FALLEN. SINCE FALLING, THE PT HAS BEEN UNABLE TO RECEIVE ADEQUATE COVERAGE. THE PT IS ALSO EXPERIENCING RIB STIMULATION. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. AN IMPEDANCE CHECK WAS PERFORMED AND REVEALED TWO INVALID CONTACTS. X-RAYS REVEALED TWO INVALID CONTACTS. X-RAYS REVEALED ONE OF THE PT'S LEADS HAS MIGRATED. THE PT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3229445

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS ANCHORS: MODEL 1192 (2)| IMPLANT:| IMPLANT:| SCS IPG: MODEL 3788