MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

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

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Cognitive Changes (2551)

Event Type  Injury  

Event Description

Okun,m.S., mann, g., foote, k.D., shapira, n.A., bowers, d., springer, u., knight, w., martin, p., goodman, w.K.Deep brain stimulation in the internal capsule and nucleus accumbens region: responses observed during active and sham programming.J.Neurol.Neurosurg.Psychiatry 2007;78;310-314.Doi:10.1136/jnnp.2006.095315.Summary: recently, anterior limb of the internal capsule and nucleus accumbens deep brain stimulation (dbs) has been used in the treatment of medication-refractory obsessive¿compulsive disorder (ocd).This region has been previously explored with lesion therapy, but with the advent of dbs there exists the possibility of monitoring the acute and chronic effects of electrical stimulation.The stimulation-induced benefits and side effects can be reversibly and blindly applied to a variety of locations in this region.To explore the acute effects of dbs in the anterior limb of the internal capsule and nucleus accumbens region.Ten total dbs leads in five patients with chronic and severe treatment-refractory ocd were tested.Patients were examined 30 days after dbs placement and received either ¿¿sham¿¿ testing or actual testing of the acute effects of dbs (the alternative condition tested 30 days later).Pooled responses were reviewed for comparability of distribution using standard descriptive methods, and relationships between the variables of interest were sought using x2 analysis.A total of 845 stimulation trials across the five patients were recorded and pooled.Of these 16% were elicited from sham stimulation and 17% from placebo (0 v stimulation).A comparison of active to sham trials showed that sham stimulation was not associated with significant side effects or responses from patients.Non-mood-related responses were found to be significantly associated with the ventral lead contacts (0 and 1) (p = 0.001).Responses such as taste, smell and smile were strongly associated with the most ventral lead positions.Similarly, physiological responses¿for example, autonomic changes, increased breathing rate, sweating, nausea, cold sensation, heat sensation, fear, panic and panic episodes¿were significantly associated with ventral stimulation (p = 0.001).Fear and panic responses appeared clustered around the most ventral electrode (0).Acute stimulation resulted in either improved or worsened mood responses in both the dorsal and ventral regions of the anterior limb of the internal capsule.The acute effects of dbs in the region of the anterior limb of the internal capsule and nucleus accumbens, particularly when obtained in a blinded fashion, provide a unique opportunity to localise brain regions and explore circuitry.Reported event: unknown number of patients experienced non-mood-related responses such as taste, smell and the motor act of smile, which were significantly associated with the ventral lead contacts during a total of 845 stimulation trials.It was noted that there were increased sensory hallucinations at higher voltage levels.The reporter stated that during the trials, there were 6 instances of a metallic smell, 10 reports of an ¿odd¿ smell, 4 reports of a sweet smell, 4 reports of a strange smell, 13 reports of a smell of ¿roses/oil/almonds,¿ 5 reports of a metallic taste, 4 reports of a sour taste, and 7 reports of an ¿odd¿ taste.The source literature included the following device specifics: lead model 3387 ies further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

Age at time of event: 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.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Concomitant medical products: product id neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator; product id 3387, lot# unknown, product type: lead.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4024644
• MDR Text Key: 20324620
• Report Number: 3007566237-2014-02333
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• 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: 07/29/2014
• 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: 00038 YR