BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3864309 · Received June 10, 2014

    Report

    Report Number
    3007566237-2014-01595
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3353, LOT# UNKNOWN, PRODUCT TYPE: ACCESSORY; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    SEIJO, F., BERAMENDI, S.A.E., LIÉBANA, E.S., ARAGONESES, B.L., AYALA, A.S., DE LEÓN, R.F., VEGA, M.A.A. SURGICAL ADVERSE EVENTS OF DEEP BRAIN STIMULATION IN THE SUBTHALAMIC NUCLEUS OF PATIENTS WITH PARKINSON'S DISEASE. THE LEARNING CURVE AND THE PITFALLS. ACTA NEUROCHIRURGICA. 2014. DOI 10.1007/S00701-014-2082-0. SUMMARY: SEVERAL SURGICAL ADVERSE EVENTS (SAES) HAVE BEEN ASSOCIATED WITH DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) IN PARKINSON¿S DISEASE (PD) PATIENTS, LEADING TO CERTAIN CONFUSION ABOUT THE RISK/BENEFIT RATIO OF THIS TECHNIQUE, AND GIVING RISE TO THE NEED OF MORE AND MORE EXTENSIVE CONTROL STUDIES OVER LONGER PERIODS. THE AIM OF THIS ARTICLE IS TO IDENTIFY AND QUANTIFY THE FACTORS ASSOCIATED WITH THE MOST FREQUENT AES FROM STN DBS IN PD-DIAGNOSED PATIENTS. THE FOLLOWING VARIABLES WERE STUDIED: ABORTED PROCEDURE, MISPLACED LEADS, INTRACRANIAL HAEMORRHAGE, AND SEIZURES. THIS STUDY WAS CARRIED OUT IN 233 PATIENTS DIAGNOSED WITH PD, WITH 455 STN ELECTRODES IMPLANTED AND FOLLOW-UP AFTER 7 (8¿14) YEARS FOLLOW UP. A TOTAL AMOUNT OF 56 SAES OCCURRED IN 49 PATIENTS (11.76 % OF TOTAL PROCEDURES, 12.31 % OF IMPLANTED LEADS, 21.03 % OF PATIENTS). SAES WERE: FIVE ABORTED PROCEDURES, 26 MISPLACED LEADS, TEN INTRACRANIAL HAEMORRHAGES, AND 15 SEIZURES. OF ALL THE SAES, LONG-TERM EFFECTS ONLY HAPPENED IN TWO CASES OF HEMIPARESIS CAUSED BY INTRACRANIAL HAEMORRHAGE; THE OTHER SAES WERE REVERSIBLE AND DIDN¿T LEAVE ANY LONG-TERM CLINICAL CONSEQUENCES (0.42 % OF PROCEDURES, 0.44 % OF LEADS, AND 0.86 % OF PATIENTS). STN DBS IN PD PATIENTS IS A SAFE SURGICAL PROCEDURE, WITH GOOD RISK/BENEFIT RATIOS: PROCEDURE RELIABILITY/ CORRECT LEAD IMPLANTATION IN 95.59 %, 0 MORTALITY/IMPLANTED LEAD, 0.12 MORBIDITY/IMPLANTED LEAD, AND 0.0043 NEUROLOGICAL SEQUELAE/IMPLANTED LEAD. REPORTED EVENTS: ONE PATIENT PRESENTED MODERATE SUBCORTICAL VENOUS HEMORRHAGE AND CONFUSION. IT WAS NOTED THAT THE EVENT LEFT NO CLINICAL CONSEQUENCES OVER TIME. ONE PATIENT HAD MODERATE INTRAVENTRICULAR HEMORRHAGE AND CONFUSION. IT WAS NOTED THAT THIS CASE ALSO PRESENTED WITH MODERATE BRAIN SWELLING. IT WAS NOTED THAT THE EVENT LEFT NO CLINICAL CONSEQUENCES OVER TIME. ONE PATIENT HAD MODERATE THALAMIC HEMORRHAGE WITH IMPAIRMENT OF CONSCIOUSNESS, WHICH LED TO AN EMERGENCY CT AND ABORTION OF THE SURGICAL PROCEDURE. IT WAS NOTED THAT THIS CASE ALSO PRESENTED WITH MODERATE BRAIN SWELLING. IT WAS NOTED THAT THE EVENT LEFT NO CLINICAL CONSEQUENCES OVER TIME. ONE PATIENT PRESENTED WITH MODERATE CORTICAL VENOUS HEMORRHAGIC INFARCTION WITH MODERATE SWELLING. THE REPORTER STATED THAT THE PATIENT ALSO SUFFERED SEIZURES. IT WAS NOTED THAT THE EVENT LEFT NO CLINICAL CONSEQUENCES OVER TIME AND THE PATIENT DID NOT REQUIRE ANTICONVULSANT TREATMENT AFTER THE HOSPITAL DISCHARGE. ONE PATIENT PRESENTED WITH MODERATE CORTICAL VENOUS HEMORRHAGIC INFARCTION WITH A LARGE AMOUNT OF SWELLING. THE REPORTER STATED THAT THE PATIENT ALSO SUFFERED SEIZURES. IT WAS NOTED THAT THE EVENT LEFT NO CLINICAL CONSEQUENCES OVER TIME AND THE PATIENT DID NOT REQUIRE ANTICONVULSANT TREATMENT AFTER THE HOSPITAL DISCHARGE ONE PATIENT SUFFERED MODERATE RIGHT THALAMIC HEMORRHAGE ALONG WITH MODERATE BRAIN SWELLING AND SEIZURES. IT WAS NOTED THAT THE EVENT LEFT NO CLINICAL CONSEQUENCES OVER TIME AND THE PATIENT DID NOT REQUIRE ANTICONVULSANT TREATMENT AFTER HOSPITAL DISCHARGE. ONE PATIENT PRESENTED MODERATE FRONTAL INTRAPARENCHYMAL HEMORRHAGE WITH BRAIN SWELLING AND SEIZURES. IT WAS NOTED THAT THE EVENT LEFT NO CLINICAL CONSEQUENCES OVER TIME AND THE PATIENT DID NOT REQUIRE ANTICONVULSANT TREATMENT AFTER HOSPITAL DISCHARGE. ONE PATIENT SHOWED A SEVERE INTRAPARENCHYMAL HEMORRHAGE LEADING TO AN EMERGENCY EVACUATION WITHOUT LEAD REMOVAL. THE REPORTER STATED THAT AS A CONSEQUENCE OF THE HEMATOMA, THE PATIENT PRESENTED WITH RESIDUAL HEMIPARESIS. IT WAS NOTED THAT THIS PATIENT ALSO SUFFERED FROM LARGE AMOUNTS OF BRAIN SWELLING ON THE HEMORRHAGIC SIDE, WITH MODERATE SWELLING ON THE CONTRALATERAL SIDE. ONE PATIENT PRESENTED MODERATE MESENCEPHALIC HEMORRHAGE AND SEIZURES. IT WAS NOTED THAT THE EVENT LEFT NO CLINICAL CONSEQUENCES OVER TIME AND THE PATIENT DID NOT REQUIRE ANTICONVULSANT TREATMENT AFTER HOSPITAL DISCHARGE. ONE PATIENT SUFFERED SEVERE INTRAPARENCHYMAL HEMORRHAGE WITH BILATERAL MODERATE BRAIN SWELLING WHICH CAUSED SEIZURES AND RESIDUAL HEMIPARESIS. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE ANTICONVULSANTS AFTER HOSPITAL DISCHARGE. FIVE PATIENTS PRESENTED SEIZURES WITH BRAIN SWELLING. FOUR PATIENTS PRESENTED SEIZURES ON A NORMAL POSTOPERATIVE CT. IT WAS NOTED THAT THESE PATIENTS PRESENTED A SINGLE TONIC-CLONIC GENERALIZED SEIZURE EPISODE WITHIN THE FIRST 12 HOURS POST-SURGERY. IT WAS NOTED THAT THE EVENT LEFT NO CLINICAL CONSEQUENCES OVER TIME AND THE PATIENTS DID NOT REQUIRE ANTICONVULSANTS AFTER HOSPITAL DISCHARGE. SIXTEEN LEADS WERE CONSIDERED MISPLACED THROUGH A LACK OF SUBTHALAMIC NUCLEUS (STN) LOCATION. THE REPORTER STATED THAT THE LEADS WERE NO IMPLANTED AS THERE WAS NOT ENOUGH REPRESENTATIVE STN ACTIVITY IN THE MICROELECTRODE (MER) RECORDINGS, LEADING TO CANCELLATION OF THE PROCEDURE, RATHERTHAN LEAVING THE DEEP BRAIN STIMULATION (DBS) LEAD IN A STRUCTURE THAT HAD NOT BEEN FULLY IDENTIFIED. ONE PATIENT HAD THE PROCEDURE ABORTED AS A RESULT OF A MECHANICAL FAILURE OF THE REGISTER SYSTEM. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: SOLETRA MODEL 7426 OR KINETRA MODEL 7428 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339802 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Other| R