UNKNOWN IMPLANTABLE NEUROSTIMULATOR

Report

Report Number: 3007566237-2018-01093
Event Type: Malfunction
Date Received: April 13, 2018
Date of Event: January 26, 2018
Report Date: April 13, 2018
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: MHY
PMA / PMN Number: P960009
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE: THE REPORTED AGE REFLECTS THE MEAN AGE OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. : THE REPORTED SEX REFLECTS THAT OF THE MAJORITY OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE (17 FEMALE; 16 MALE). DATE OF EVENT: 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. PRODUCT CODE MHY AND PMA# P960009 WERE USED AS THEY REFLECT THE MAJORITY OF THE PATIENTS WHO WERE IMPLANTED FOR PARKINSON'S DISEASE REPORTED IN THE LITERATURE ARTICLE. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. MATIAS, C. M., FRIZON, L. A., NAGEL, S. J., LOBEL, D. A., MACHADO, A. G. (2018). DEEP BRAIN STIMULATION OUTCOMES IN PATIENTS IMPLANTED UNDER GENERAL ANESTHESIA WITH FRAME-BASED STEREOTAXY AND INTRAOPERATIVE MRI. JOURNAL OF NEUROSURGERY, 1-7. DOI:10.31 71/2017.7.JNS171166. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

SUMMARY: OBJECTIVE THE AUTHORS¿ AIM IN THIS STUDY WAS TO EVALUATE PLACEMENT ACCURACY AND CLINICAL OUTCOMES IN PATIENTS WHO UNDERWENT IMPLANTATION OF DEEP BRAIN STIMULATION DEVICES WITH THE AID OF FRAME-BASED STEREOTAXY AND INTRAOPERATIVE MRI AFTER INDUCTION OF GENERAL ANESTHESIA. METHODS THIRTY-THREE PATIENTS WITH MOVEMENT DISORDERS (27 WITH PARKINSON¿S DISEASE) UNDERWENT IMPLANTATION OF UNILATERAL OR BILATERAL DEEP BRAIN STIMULATION SYSTEMS (64 LEADS TOTAL). ALL PATIENTS UNDERWENT THE IMPLANTATION PROCEDURE WITH STANDARD FRAME-BASED TECHNIQUES UNDER GENERAL ANESTHESIA AND WITHOUT MICROELECTRODE RECORDING. MR IMAGES WERE ACQUIRED IMMEDIATELY AFTER THE PROCEDURE AND FUSED TO THE PREOPERATIVE PLAN TO VERIFY ACCURACY. TO EVALUATE CLINICAL OUTCOME, DIFFERENT SCALES WERE USED TO ASSESS QUALITY OF LIFE (EQ-5D), ACTIVITIES OF DAILY LIVING (UNIFIED PARKINSON¿S DISEASE RATING SCALE [UPDRS] PART II), AND MOTOR FUNCTION (UPDRS PART III DURING OFF- AND ON-MEDICATION AND OFF- AND ON STIMULATION STATES). ACCURACY WAS ASSESSED BY COMPARING THE COORDINATES (X, Y, AND Z) FROM THE PREOPERATIVE PLAN AND COORDINATES FROM THE TIP OF THE LEAD ON INTRAOPERATIVE MRI AND POSTOPERATIVE CT SCANS. RESULTS THE EQ-5D SCORE IMPROVED OR REMAINED STABLE IN 71% OF THE PATIENTS. WHEN IN THE OFF MEDICATION/ON STIMULATION STATE, ALL PATIENTS REPORTED SIGNIFICANT IMPROVEMENT IN UPDRS III SCORE AT THE LAST FOLLOW-UP (P < 0.001), WITH A REDUCTION OF 25.2 POINTS (46.3%) (SD 14.7 POINTS AND 23.5%, RESPECTIVELY). THERE WAS IMPROVEMENT OR STABILITY IN THE UPDRS II SCORES FOR 68% OF THE PARKINSON¿S PATIENTS. FOR 2 PATIENTS, THE STEREOTACTIC ERROR WAS DEEMED SIGNIFICANT BASED ON INTRAOPERATIVE MRI FINDINGS. IN THESE PATIENTS, THE LEAD WAS REMOVED AND REPLACED AFTER CORRECTING FOR THE ERROR DURING THE SAME PROCEDURE. POSTOPERATIVE LEAD REVISION WAS NOT NECESSARY IN ANY OF THE PATIENTS. BASED ON FINDINGS FROM THE LAST INTRAOPERATIVE MRI STUDY, THE MEAN DIFFERENCE BETWEEN THE TIP OF THE ELECTRODE AND THE PLANNED TARGET WAS 0.82 MM (SD 0.5 MM, P = 0.006) FOR THE X-AXIS, 0.67 MM (SD 0.5 MM, P < 0.001) FOR THE Y-AXIS, AND 0.78 MM (SD 0.7 MM, P = 0.008) FOR THE Z-AXIS. ON AVERAGE, THE EUCLIDIAN DISTANCE WAS 1.52 MM (SD 0.6 MM). IN PATIENTS WHO UNDERWENT BILATERAL IMPLANTATION, ACCURACY WAS FURTHER EVALUATED COMPARING THE FIRST IMPLANTED SIDE AND THE SECOND IMPLANTED SIDE. THERE WAS A SIGNIFICANT MEDIOLATERAL (X-AXIS) DIFFERENCE (P = 0.02) IN LEAD ACCURACY BETWEEN THE FIRST (MEAN 1.02 MM, SD 0.57 MM) AND THE SECOND (MEAN 0.66 MM, SD 0.50 MM) SIDES. HOWEVER, NO SIGNIFICANT DIFFERENCE WAS FOUND FOR THE Y- AND Z-AXES (P = 0.10 AND P = 0.89, RESPECTIVELY). CONCLUSIONS FRAME-BASED DBS IMPLANTATION UNDER GENERAL ANESTHESIA WITH INTRAOPERATIVE MRI VERIFICATION OF LEAD LOCATION IS SAFE, ACCURATE, PRECISE, AND EFFECTIVE COMPARED WITH STANDARD IMPLANTATION PERFORMED USING AWAKE INTRAOPERATIVE PHYSIOLOGY. MORE CLINICAL TRIALS ARE NECESSARY TO DIRECTLY COMPARE OUTCOMES OF EACH TECHNIQUE. REPORTED EVENTS: THERE WAS A SIGNIFICANT STEREOTACTIC ERROR FOUND VIA AN INTRAOPERATIVE MRI FOR 1 PATIENT. THE LEAD WAS REMOVED AND REPLACED AFTER CORRECTING FOR THE ERROR DURING THE SAME PROCEDURE. AN ERROR OF 3.0 MM LATERAL TO THE INTENDED TARGET WAS REPORTED. THE HEALTH CARE PROVIDER (HCP) SPECULATED THAT THIS ERROR MAY BE RELATED TO THE STEREOTACTIC CORRECTION THEY APPLIED AFTER EVALUATING THE EXTENT AND DIRECTION OF ERROR ON THE INTRAOPERATIVE SCAN AFTER THE FIRST LEAD WAS IMPLANTED IN ONE HEMISPHERE. THERE WAS A SIGNIFICANT STEREOTACTIC ERROR FOUND VIA AN INTRAOPERATIVE MRI FOR 1 PATIENT. THE LEAD WAS REMOVED AND REPLACED AFTER CORRECTING FOR THE ERROR DURING THE SAME PROCEDURE. AN ERROR OF 2.5 MM MEDIAL AND 1.0 POSTERIOR TO THE PLANNED TARGET WAS REPORTED. THE HEALTH CARE PROVIDER (HCP) SPECULATED THAT THIS ERROR MAY BE RELATED TO THE STEREOTACTIC CORRECTION THEY APPLIED AFTER EVALUATING THE EXTENT AND DIRECTION OF ERROR ON THE INTRAOPERATIVE SCAN AFTER THE FIRST LEAD WAS IMPLANTED IN ONE HEMISPHERE. IN AN UNKNOWN AMOUNT OF PATIENTS WHO UNDERWENT BILATERAL IMPLANTATION, THERE WAS A SIGNIFICANT MEDIOLATERAL (X-AXIS) DIFFERENCE I N LEAD ACCURACY BETWEEN THE FIRST AND THE SECOND LEAD IMPLANTS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
272003	UNKNOWN IMPLANTABLE NEUROSTIMULATOR	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC NEUROMODULATION	NEU_INS_STIMULATOR

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR