BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 14431317 · Received May 18, 2022

    Report

    Report Number
    2182207-2022-00815
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    January 10, 2022
    Report Date
    May 17, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389, PRODUCT TYPE: LEA. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INÊS ANTUNES CUNHA, INÊS CARVALHO, CRISTIANA SILVA, PEDRO MONTEIRO, RICARDO PEREIRA, FRADIQUE MOREIRA. PERI-LEAD EDEMA AFTER DEEP BRAIN STIMULATION SURGERY FOR PARKINSON DISEASE: A MANAGEMENT CHALLENGE. SINAPSE. DOI: 10.46531/SINAPSE/CC/210068/2022. ABSTRACT: DEEP BRAIN STIMULATION (DBS) IS A WELL-ESTABLISHED SURGICAL TREATMENT FOR PARKINSON¿S DISEASE. PERI-LEAD EDEMA (PLE) IS A POORLY UNDERSTOOD COMPLICATION OF DBS. WE HEREBY REPORT THREE CASES OF UNILATERAL PLE AFTER BILATERAL SUBTHALAMIC NUCLEUS (STN)-DBS AND DISCUSS ITS DIAGNOSIS AND MANAGEMENT. PATIENT 1 REPORTED A NEW-ONSET HEADACHE ONE MONTH AFTER HIS SURGICAL PROCEDURE. ANTIBIOTIC TREATMENT WAS ADMINISTERED. HIS COMPLAINT RESOLVED TWO DAYS LATER. PATIENT 2 PRESENTED IN AN ACUTE CONFUSIONAL STATE ON THE SEVENTH POST-OPERATIVE DAY. HE WAS TREATED WITH CORTICOSTEROID. WITHIN A FEW DAYS CLEAR CLINICAL IMPROVEMENT WAS SEEN. PATIENT 3 DEVELOPED PLE 56 HOURS POSTOPERATIVELY. HE REMAINED ASYMPTOMATIC AND THE EDEMA IMPROVED COMPLETELY WITHOUT ANY TREATMENT. TWO PATIENTS SHOWED AN ABRUPT CHANGE IN IMPEDANCE EVALUATION. PLE IS AN UNDERESTIMATED COMPLICATION OF DBS. IT IS CLINICALLY HETEROGENEOUS AND ITS MANAGEMENT IS STILL LACKING. IMPEDANCE EVALUATION CAN HELP IN ITS EARLY RECOGNITION, AVOIDING UNNECESSARY MEDICAL OR SURGICAL PROCEDURES. REPORTED EVENTS: 1. IT WAS REPORTED THAT A 47 YEAR OLD MALE PATIENT UNDERWENT BILATERAL SUBTHALMIC NUCLEUS DEEP BRAIN STIMULATION (STN DBS) IMPLANTATION FOR PARKINSON'S DISEASE. THE SURGICAL PROCEDURE WAS UNEVENTFUL AND POSTOPERATIVE HEAD COMPUTED TOMOGRAPHY (CT) SCAN 4 DAYS AFTER SURGERY SHOWED GOOD ELECTRODE PLACEMENT AND NO ABNORMALITIES. ONE MONTH LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF A NEW-ONSET HEADACHE. THEY DESCRIBED A BILATERAL FONTAL HEADACHE THAT WOULD NOT GO AWAY WITH PRESCRIBED PAIN MEDICATIONS. NEUROLOGICAL EXAM CONFIRMED GOOD RESPONSE TO DBS AND NO OTHER NEUROLOGICAL SIGNS WERE IDENTIFIED. A HEAD CT SCAN REVEALED A RIGHT PERI-LEAD EDEMA (PLE). THEY INITIALLY REFUSED LUMBAR PUNCTURE AND WERE COMMENCED ON CEFRADINE. ALL INFECTIVE WORKUP WAS SUBSEQUENTLY NEGATIVE. THEIR SYMPTOMS SUBSIDED AFTER TWO DAYS AND DID NOT RECUR. A FOLLOW UP CT SHOWED IMPROVEMENT OF THE EDEMA 14 MONTHS AFTER THE SYMPTOMS.  2. IT WAS REPORTED THAT A 61 YEAR OLD MALE PATIENT UNDERWENT BILATERAL STN DBS IMPLANTATION FOR PARKINSON'S DISEASE. DURING THE SURGICAL PROCEDURE A SECOND CANNULA PASSAGE WAS PERFORMED TO CORRECT ITS DEVIATION. THE CONTROL HEAD CT SCAN ON THE 2ND POSTOPERATIVE DAY WAS NORMAL. SEVEN DAYS LATER THEY DEVELOPED AN ACUTE CONFUSION STATE. NEUROLOGICAL EXAMINATION REVEALED ONLY MILD CONFUSION, WITH NO CHANGED IN CLINICAL RESPONSE TO DBS. THE IMPEDANCE EVALUATION WAS LOWER IN THE RIGHT ELECTRODE (396OHMS VS 834 OHMS). A HEAD CT SCAN REVEALED A SIGNIFICANT RIGHT PLE, SO THEY WERE GIVEN A LOW DOSE OF DEXAMETHASONE (2MG FOR 5 DAYS, 1MG FOR 3 DAYS, THEN 0.5MG FOR 3 DAYS). SYMPTOM RECOVERY TOOK 5 DAYS AND A FOLLOW UP CT SCAN DEMONSTRATED IMPROVEMENT OF THE EDEMA 15 DAYS AFTER THE SYMPTOMS ONSET. NO FURTHER EVENTS WERE OBSERVED.  3. IT WAS REPORTED THAT A 60 YEAR OLD MALE UNDERWENT STN DBS IMPLANTATION FOR PARKINSON'S DISEASE. THERE WERE NO INTRAOPERATIVE COMP LICATIONS. DURING CLINICAL EVALUATION AFTER THE SURGICAL PROCEDURE THE IMPEDANCE MEASUREMENT WAS CLEARLY ASYMMETRIC, SHOWING MARKED DECREASED IN THE RIGHT ELECTRODE (550OHMS VS 1709OHMS). HEAD CT SCAN 56 HOURS POSTOPERATIVELY DEMONSTRATED A RIGHT PLE. EDEMA WAS STILL VISIBLE IN A FOLLOW UP CT SCAN 16 DAYS LATER. THEY REMAINED ASYMPTOMATIC AND NOT TREATMENTS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711117 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention