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

Model Number 37601

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

Patient Problems Anxiety (2328); Irritability (2421); Cognitive Changes (2551)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

Patient age: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Lotta winter, assel saryyeva, kerstin schwabe, hans e.Heissler, joachim runge, mesbah alam, ivo heitland, kai g.Kahl, joachim k.Krauss.Neuromodulation: technology at the neural interface.Doi: 10.1111/ner.13232 abstract background: obsessive compulsive disorder (ocd) is a severe disabling disease, and around 10% of patients are considered to be treat ment-resistant (tr) in spite of guideline-based therapy.Deep brain stimulation (dbs) has been proposed as a promising treatment for patients with trocd.However, the optimal site for stimulation is still a matter of debate, and clinical longterm follow-up observations including data on quality of life are sparse.We here present six trocd patients who underwent dbs with electrodes placed in the bed nucleus of the stria terminalis/anterior limb of the internal capsule (bnst/alic), followed for four to eight years after lead implantation.Materials and methods: in this prospective observational study, six patients (four men, two women) aged 32¿51 years and suffering from severe to extreme trocd underwent dbs of the bnst/alic.Symptom severity was assessed using the yale- brown obsessive compulsive scale (y-bocs), and quality of life using the world health organization quality of life assessment scale (who-qol bref).Follow-up was obtained at least for four years in all patients.Results: with chronic dbs for four to eight years, four of the six patients had sustained improvement.Two patients remitted and two patients responded (defined as >35% symptom reduction), while the other two patients were considered nonresponders on long-term.Quality of life markedly improved in remitters and responders.We did not observe peri-interventional side effects or adverse effects of chronic stimulation.Conclusions: chronic dbs of alic provides long-term benefit up to four to eight years in trocd, although not all patients take profit.Targeting the bnst was not particularly relevant since no patient appeared to benefit from direct stimulation of the bnst.Quality of life improved in dbs responders, documented by improved qol scores and, even more important, by regaining of autonomy and improving psychosocial functioning.Keywords: case series, deep brain stimulation for obsessive-compulsive disorder, long-term electrical stimulation of bed nucleus of stria termi, obsessive compulsive disorder, stimulation conflict of interest: dr.Kahl reports advisory relationship with neuraxpharm, takeda, and trommsdorff/ ferrer outside the submitted work.Dr.Kahl reports personal fees from elililly, personal fees from janssen/j<(>&<)>j, personal fees and other from neuraxpharm, personal fees from otsuka, personal fees from pfizer, personal fees from schwabe, personal fees and other from servier, personal fees and other from takeda, and personal fees from trommsdorff/ ferrer outside the submitted work.Dr.Winter reports personal fees from servier.Pli 2: it was reported that the patient was in remission of symptom, although they still had single symptoms including sporadic controlling behavior.It was reported that the patient became aggressive without any reason.The patient also felt feelings of insecurity and anxiousness.At the 24 months checkup they became particularly disorganized, less concentrated, and unconcerned with tidiness.They reported loss of interests and activities that they had enjoyed once and began to isolate themselves.Episodes of abrupt aggression in the context of delusions and acoustic hallucinations became more frequent.At that point diagnostic criteria of a schizophrenia were fulfilled, and treatment with medications were started.At the last visit their ocd symptoms were absent, schizophrenia symptoms were stable, and behavioral disturbances had improved.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10512344
• MDR Text Key: 206352412
• Report Number: 2182207-2020-00844
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• 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): Required Intervention
• Patient Age: 39 YR