MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Human-Device Interface Problem (2949)

Patient Problems Apnea (1720); Unspecified Infection (1930); Urinary Retention (2119); Cognitive Changes (2551)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

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.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 device was used in an off-label manner; the main component of one of the systems involved in the reported events; other applicable components are: product id: neu_unknown_lead, lot# unknown, product type: lead.Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator.Raymaekers, s., luyten, l., bervoets, c., gabriels, l., nuttin, b.Deep brain stimulation for treatment-resistant major depressive disorder: a comparison of two targets and long-term follow-up.Transl psychiatry.2017;7(10):e1251.Doi:10.1038/tp.2017.66.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Summary: we previously found that electrical stimulation in the anterior limb of the internal capsule/bed nucleus of the stria terminalis (ic/bst) alleviates depressive symptoms in severe treatment-resistant obsessive-compulsive disorder (ocd) patients.Here we tested the hypothesis that electrical stimulation in either ic/bst or in the inferior thalamic peduncle (itp) effectively reduces depressive symptoms in treatment-resistant major depressive disorder (trd).In a double-blind crossover design, the effects of electrical stimulation at both targets were compared in trd patients.The 17-item hamilton depression rating scale (ham-d) was the primary outcome measure.During the first crossover, patients received ic/bst stimulation versus no stimulation in random order (2 × 1 weeks).During the second crossover (3 × 2 months), patients received ic/bst versus itp versus no stimulation.Patients and evaluators were blinded for stimulation conditions.All patients (n = 7) were followed up for at least 3 years (3¿8 years) after implantation.Six patients completed the first crossover and five patients completed the second.During the first crossover, mean (s.D.) ham-d scores were 21.5 (2.7) for no stimulation and 11.5 (8.8) for ic/bst stimulation.During the second crossover, ham-d scores were 15.4 (7.5) for no stimulation, 7.6 (3.8) for ic/bst stimulation and 11.2 (7.5) for itp stimulation.The final sample size was too small to statistically analyze this second crossover.At last follow-up, only one patient preferred itp over ic/bst stimulation.Two patients, with a history of suicide attempts before implantation, committed suicide during the follow-up phases of this study.Our data indicate that, in the long term, both itp and ic/bst stimulation may alleviate depressive symptoms in patients suffering from trd.Reported events: pli 10: an unknown number of patients with deep brain stimulation (dbs) leads bilaterally targeting the internal capsule/bed nucleus of the stria terminalis (ic/bst) and the inferior thalamic peduncle (itp) for treatment resistant depression (trd) experienced cognitive/behavioral adverse events that were reportedly stimulation induced.Under stimulation of the ic/bst the authors reported: 1 instance of intrusive thoughts about violent suicide; 1 instance of hearing the voice of their deceased sister; 1 instance of a feeling of derealization; 1 instance of disruption of social skills; 1 instance of increased impulsivity; and 2 instances of concentration difficulties.Under stimulation of the itp the authors reported: 1 instance of obsessive counting; and 1 instance of compulsive stealing.Pli 20: a patient who received 4 dbs leads bilaterally targeting the ic/bst and the itp for trd reportedly had a surgery/device related adverse event relating to their leads being ¿conversely labelled¿ resulting in the itp being stimulated when they expected the ic/bst to be stimulated.This reportedly led to an additional surgical procedure.Pli 30: a patient with dbs leads bilaterally targeting the ic/bst and the itp for trd experienced damage of the internal capsule electrode.This reportedly led to an additional surgical procedure.Pli 40: a patient with dbs leads bilaterally targeting the ic/bst and the itp for trd experienced an infection around the stereotactic frame attachment site.Pli 50: 2 patients with dbs leads bilaterally targeting the ic/bst and the itp for trd experienced an infection around the implantable neurostimulator (ins).This reportedly led to an additional surgical procedure.Pli 60: a patient with dbs leads bilaterally targeting the ic/bst and the itp for trd experienced sleep apnea that was reportedly induced by stimulation of the itp.Pli 70: a patient with dbs leads bilaterally targeting the ic/bst and the itp for trd experienced urinary retention that was reportedly induced by stimulation of the ic/bst.The authors reported that patients were eventually implanted with model 37612 activa rc's, however the original ins models were not stated.They also reported patients 1-5 received 3387 and patients 6-7 received 3389 model leads.It was not possible to ascertain any additional specific device information from the article or to match the reported event with any previously reported event.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7253194
• MDR Text Key: 99560634
• Report Number: 3007566237-2018-00407
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• 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): Life Threatening; Other; Required Intervention
• Patient Age: 49 YR