BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7635597 · Received June 25, 2018

    Report

    Report Number
    3007566237-2018-01883
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    April 11, 2018
    Report Date
    August 23, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    LEE, P.S., WEINER, G.M., CORSON, D., KAPPEL, J., CHANG, Y.F., SUSKI, V.R., BERMAN, S.B., HOMAYOUN, H., VAN LAAR, A.D., CRAMMOND, D.J., RICHARDSON, R.M. OUTCOMES OF INTERVENTIONAL-MRI VERSUS MICROELECTRODE RECORDING- GUIDED SUBTHALAMIC DEEP BRAIN STIMULATION. FRONT. NEUROL. 2018; 9:241. DOI: 10.3389/FNEUR.2018.00241. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ASKU ; PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: IN DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) FOR PARKINSON¿S DISEASE (PD), THERE IS DEBATE CONCERNING THE USE OF NEUROIMAGING ALONE TO CONFIRM CORRECT ANATOMIC PLACEMENT OF THE DBS LEAD INTO THE STN, VERSUS THE USE OF MICROELECTRODE RECORDING (MER) TO CONFIRM FUNCTIONAL PLACEMENT. THE AUTHORS PERFORMED A RETROSPECTIVE STUDY OF A CONTEMPORANEOUS COHORT OF 45 CONSECUTIVE PATIENTS WHO UNDERWENT EITHER INTERVENTIONAL- MRI (IMRI) OR MER-GUIDED DBS LEAD IMPLANTATION. THE AUTHORS COMPARED RADIAL LEAD ERROR, MOTOR AND SENSORY SIDE EFFECT, AND CLINICAL BENEFIT PROGRAMMING THRESHOLDS, AND PRE- AND POST-OPERATIVE UNIFIED PD RATING SCALE SCORES, AND LEVODOPA EQUIVALENT DOSAGES. MER- GUIDED SURGERY WAS ASSOCIATED WITH GREATER RADIAL ERROR COMPARED TO THE INTENDED TARGET. IN GENERAL, SIDE EFFECT THRESHOLDS DURING INITIAL PROGRAMMING WERE SLIGHTLY LOWER IN THE MER GROUP, BUT CLINICAL BENEFIT THRESHOLDS WERE SIMILAR. NO SIGNIFICANT DIFFERENCE IN THE REDUCTION OF CLINICAL SYMPTOMS OR MEDICATION DOSAGE WAS OBSERVED. IN SUMMARY, IMRI LEAD IMPLANTATION OCCURRED WITH GREATER ANATOMIC ACCURACY, IN LOCATIONS DEMONSTRATED TO BE THE APPROPRIATE FUNCTIONAL REGION OF THE STN, BASED ON THE OBSERVATION OF SIMILAR PROGRAMMING SIDE EFFECT AND BENEFIT THRESHOLDS OBTAINED WITH MER. THE PRODUCTION OF EQUIVALENT CLINICAL OUTCOMES SUGGESTS THAT SURGEON AND PATIENT PREFERENCE CAN BE USED TO GUIDE THE DECISION OF WHETHER TO RECOMMEND IMRI OR MER-GUIDED DBS LEAD IMPLANTATION TO APPROPRIATE PATIENTS WITH PD. REPORTED EVENTS: ONE PATIENT UNDERGOING DEEP BRAIN STIMULATION (DBS) IMPLANT WITH IMRI HAD SMALL CORTICAL HEMORRHAGE. THE PROCEDURE WAS ABORTED. THE HEMORRHAGE WAS DEEMED ASYMPTOMATIC IN POSTOPERATIVE EXAM. ONE PATIENT IMPLANTED WITH BILATERAL STN DBS FOR PARKINSON'S DISEASE EXPERIENCED POSTOPERATIVE STATUS EPILEPTICUS AND WAS TREATED WITH ANTI-EPILEPTIC MEDICATION. THE PATIENT REQUIRED INTUBATION FOR AIRWAY MANAGEMENT UNTIL SEIZURES WERE CONTROLLED, AND MADE A FULL RECOVERY. NO ETIOLOGY WAS FOUND TO ACCOUNT FOR THE SEIZURE ONSET. ONE PATIENT IMPLANTED WITH BILATERAL STN DBS FOR PARKINSON'S DISEASE EXPERIENCED POSTOPERATIVE INFECTION. THE INFECTION OCCURRED TWO MONTHS POST-OPERATIVELY AT BURR HOLE INCISION, AND MRI DEMONSTRATED BRAIN ABSCESS. THE SYSTEM WAS REMOVED AND THE PATIENT RECEIVED SIX WEEK INTRAVENOUS ANTIBIOTIC THERAPY. THE SYSTEM WAS REPLACED AFTER A FULL RECOVERY BY THE PATIENT. ONE PATIENT IMPLANTED WITH BILATERAL STN DBS FOR PARKINSON'S DISEASE EXPERIENCED POSTOPERATIVE INFECTION. THE INFECTION WAS A STITCH ABSCESS AT BURR HOLE INCISION TWO MONTHS AFTER IMPLANT. THE PATIENT HAD A FULL RECOVERY AFTER SURGICAL DEBRIDEMENT WITHOUT HARDWARE EXPLANT AND SIX WEEKS OF INTRAVENOUS ANTIBIOTICS. ONE PATIENT IMPLANTED WITH BILATERAL STN DBS FOR PARKINSON'S DISEASE EXPERIENCED A UNILATERAL LEAD EXTENDER FRACTURE. THE DEVICE WAS REPLACED. NO DEVICE SPECIFICS COULD BE IDENTIFIED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478133 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| O| R