BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1910889 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03640
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 2 OF 3. REFERENCE MANUFACTURER REPORTS: 1627487-2010-03639 AND 1627487-2010-03641. THE PT RECEIVED AN SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS, ON (B)(6) 2010. THE PT REPORTED HE FELT HIS STIMULATION MOVING AND, THEREFORE, REQUIRED CONSTANT REPROGRAMMING. AS THE PHYSICIAN FELT THE PT WOULD BENEFIT FROM A PADDLE LEAD, HIS PERCUTANEOUS LEADS WERE EXPLANTED AND REPLACED WITH ONE PADDLE LEAD. POST-OPERATIVE, THE PT FELT PAIN IN HIS RIGHT FOOT THAT HAD NOT BEEN THERE PRE-OPERATIVE. A CT SCAN WAS PERFORMED BUT NO ANOMALIES WERE SEEN. THE PADDLE LEAD WAS EXPLANTED AND NOT IMMEDIATELY REPLACED. THE PHYSICIAN HAS INDICATED A NEW LEAD WILL BE IMPLANTED AT A LATER DATE. THE LOT NUMBER OF THE PADDLE LEAD WAS NOT PROVIDED; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES COULD NOT BE DETERMINED. FOLLOW UP ON THE PT FOUND THAT THE PAIN IN HIS FOOT IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2819721

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention