BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110597 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-08059
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    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 INFO 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: 1627487-2013-08070. THE PT RECEIVED TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS HAVING INEFFECTIVE PAIN COVERAGE AND SURGES. X-RAY IMAGERY REVEALED THE LEAD WAS LOOSE AND WAS OUT OF THE IPG (IMPLANTABLE PULSE GENERATOR) HEADER. DURING THE PROCEDURE TO RECONNECT THE LEADS, SEVERAL INVALID LEAD CONTACTS WERE OBSERVED. ONE OF THE LEADS WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208517 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3853490

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)