MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION

Model Number NEU_INS_STIMULATOR

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

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Cognitive Changes (2551)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.

Event Description

Mulders, aep., leentjens, afg., schruers, k., duits, a., ackermans, l., temel, y.Choreatic side-effects of deep brain stimulation of the anteromedial subthalamic nucleus for treatment-resistant obsessive-compulsive disorder: a case report.World neurosurg.2017.Doi: 10.1016/j.Wneu.2017.05.067 summary: background: patients with treatment-resistant obsessive-compulsive disorder (ocd) are potential candidates for deep brain stimulation (dbs).The anteromedial subthalamic nucleus (stn) is amongst the most commonly used targets for dbs in ocd.Case description: we present a patient with a 30-year history of treatment-resistant ocd who underwent anteromedial stn-dbs.Despite a clear mood-enhancing effect, stimulation caused motor side-effects including bilateral hyperkinesia, dyskinesias and sudden large amplitude choreatic movements of arms and legs when stimulating at voltages above circa 1.5v.Dbs at lower amplitudes and at other contact points failed to result in a significant reduction of obsessions and compulsions without inducing motor side-effects.Due to this limitation in programming options, we decided to re-operate and target the ventral capsule/ventral striatum (vc/vs), which resulted in a substantial reduction in key obsessive and compulsive symptoms without serious side-effects.Conclusion: choreatic movements and hemiballismus have previously been linked to stn dysfunction and have been incidentally reported as side-effect of dbs of the dorsolateral stn in parkinson's disease (pd).However, in pd, these side-effects were usually transient and rarely interfered with dbs programming.In our case, the motor side-effects were persistent and made optimal dbs programming impossible.To our knowledge such severe a nd persistent motor side effects have not yet been described for anteromedial stn-dbs.Reported events: a (b)(6) female patient who received bilateral deep brain stimulation (dbs) of the subthalamic nucleus (stn) for obsessive compulsive disorder (ocd) developed unexpected compulsive behavior towards their operation wounds, including scratching and itching, which the authors felt likely contributed to the development of a hardware infection.The infection was treated with removing the infected implantable neurostimulator (ins) and cables and antibiotic therapy.Two months later a new dbs was implanted and therapy reactivated.It was noted that the patient was implanted with 3389 model lead, but it was not possible to ascertain any further specific device information from the article or to match the reported event with any previously reported event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6682636
• MDR Text Key: 78900240
• Report Number: 3007566237-2017-02619
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/13/2017
• 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: 49 YR