MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Emotional Changes (1831); Erythema (1840); Fatigue (1849); Headache (1880); Hematoma (1884); Itching Sensation (1943); Nausea (1970); Pain (1994); Vertigo (2134); Cognitive Changes (2551); Convulsion/Seizure (4406); Paresthesia (4421); Insufficient Information (4580)

Event Date 04/27/2022

Event Type  Injury  

Event Description

Jessica c.Scaife, john eraifej, alexander l.Green, beth petric, tipu z.Aziz and rebecca j.Park.Deep brain stimulation of the nucleus accumbens in severe enduring anorexia nervosa: a pilot study.Frontiers in behavioral neuroscience.Doi: 10.3389/fnbeh.2022.842184.Introduction: anorexia nervosa (an) is one of the most debilitating psychiatric disorders, becoming severe and enduring in a third of cases; with few effective treatments.Deep brain stimulation is a reversible, adjustable neurosurgical procedure that has been gaining ground in psychiatry as a treatment for depression and obsessive¿ compulsive disorder, yet few studies have investigated an.Abnormal eating behavior and the compulsive pursuit of thinness in an is, in part, a consequence of dysfunction in reward circuitry and the nucleus accumbens (nacc) is central to reward processing.Methods: phase 1 prospective open-label pilot study of seven individuals with severe enduring an.Electrodes were implanted bilaterally into the nacc with stimulation at the anterior limb of the internal capsule using rechargeable implantable pulse generators.The protocol of 15 months included 12 months of deep brain stimulation incorporating two consecutive, randomized blind on-off fortnights 9 months after stimulation onset.The primary objectives were to investigate safety and feasibility, together with changes in eating disorder psychopathology.Results: feasibility and safety was d emonstrated with no serious adverse events due to deep brain stimulation.Three patients responded to treatment [defined as > 35% reduction in eating disorders examination (ede) score at 12 months] and four patients were non-responders.Responders had a statistically significant mean reduction in ede scores (50.3% reduction; 95% ci 2.6¿98.2%), clinical impairment assessment (45.6% reduction; 95% ci 7.4¿83.7%).Responders also had a statistically significant mean reduction in hamilton depression scale, hamilton anxiety scale and snaith-hamilton pleasure scale.There were no statistically significant changes in body mass index, yale- brown-cornell eating disorder scale, yale-brown obsessive¿compulsive scale and world health organization quality of life psychological subscale.Reported events: 1.Patient 5: it was reported that a 58 year old female underwent bilateral implantation in the nucelus accumbens for anorexia nervosa.The patient experienced a shallow right frontal extradural hematoma that was asymptomatic and treated conservatively, not requiring surgery.They also had short term side effects after surgery that included scalp pain, headache, tingling, trouble concentrating, sleepiness, mood change.There were no long term side effects, but the patient wasn't considered a responder to therapy.2.Patient 6: it was reported that a 25 year old female underwent bilateral implantation in the nucelus accumbens for anorexia nervosa.The patient needed a wound revision at 3 months under local anesthesia.They also experienced short term sideeffects after surgery that included headache, neck pain, itching, skin redness, sleepiness, trouble concentrating, sever shoulder pain, subjective short term memory impairment and word finding difficulties, change in taste of food and drink, nausea at high voltages (4v which reduced when turned to 3.75v), vertigo, travel sickness.Long term side effects included headache, neck pain sleepiness, trouble concentrating, nausea, vertigo, travel sickness.The patient was considered a responder to therapy.3.Patient 7: it was reported that a 30 year old female underwent bilateral implantation in the nucelus accumbens for anorexia nervosa.The patient experienced a possible intraoperative seizure and short term side effects after surgery that included sleepiness and headaches.There were no long term side effects.

Manufacturer Narrative

Concomitant medical products: product id: 37612, serial# unknown, product type: implantable neurostimulator.Product id: 37612, product type: implantable neurostimulator.Other relevant device(s) are: product id: 37612, serial/lot #: unknown, product id: 37612, serial/lot #: unknown.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.The devices were used for an off label indication.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14627411
• MDR Text Key: 294837779
• Report Number: 2182207-2022-01015
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female