BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTORDE

    MDR report key: 2973550 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-01182
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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: 1627487-2013-1183. IT WAS REPORTED THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION. THE PT WAS SCHEDULED FOR A PADDLE REVISION ON (B)(6) 2013, BUT UPON PLACING THE PT ON TABLE, HE BEGAN HAVING CARDIAC ISSUES. THIS OCCURRED PRIOR TO PREP AND THE PROCEDURE HAD NOT YET BEGUN. THE PROCEDURE WAS ABORTED AND THE PT WAS ADMITTED TO ICU. FOLLOW UP INFO IDENTIFIED THE PT IS DOING BETTER AND UNDERWENT REVISION SURGERY ON (B)(6) 2013 WHERE HIS LEADS WERE REPLACED WITH A NEW LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72517 OCTORDE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3382890

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| SCS IPG: MODEL 3788| IMPLANT DATE: