BEUDAMED
    FDA Adverse Event Death Summary report: N

    OCTRODE 8 PERCUTANEOUS LEAD

    MDR report key: 1509725 · Received October 15, 2009

    Report

    Report Number
    1627487-2009-00053
    Event Type
    Death
    Date Received
    October 15, 2009
    Date of Event
    October 6, 2009
    Report Date
    October 7, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM ON OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ANS WAS ADVISED IN 2009, THAT A PT WITH COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS AT T7-T9 FOR LOW BACK AND BILATERAL LEG PAIN THE DAY BEFORE. AFTER THE LEADS WERE PLACED, THE PT BEGAN VOMITING. THE MD SUBSEQUENTLY IMPLANTED THE IPG. THE MD STATED THE PT BLED MORE THAN NORMAL AND REQUIRED MORE ELECTROCAUTERY THAN NORMAL. IN THE RECOVERY ROOM, STIMULATION WAS CONFIRMED THEN THE STIMULATION WAS TURNED OFF. POST-OP THE MD ADVISED THE PT'S SPOUSE THAT THE PT BECAME ILL DURING THE PROCEDURE, AND THAT THE PT WAS NOT TO EAT ANYTHING AFTER MIDNIGHT. THE SPOUSE STATED THAT THE PT HAD EATEN EARLY THE MORNING OF THE PROCEDURE. POST-OP, IT TOOK THE HOSPITAL STAFF SOMETIME TO CLEAR THE PT'S LUNGS. IT WAS REPORTED THE PT FELL BEFORE LEAVING THE HOSPITAL AND THEN AGAIN AFTER RETURNING HOME. THE SALES REP WAS ADVISED ON THE DAY AFTER IMPLANT THAT THE PT PASSED AWAY DURING THE NIGHT OR EARLY MORNING. THE REASON FOR THE DEATH WAS UNK AND AWAITING THE RESULTS OF AN AUTOPSY. ADDITIONAL INFO HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 8 PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 173195

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death