MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problems Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Neurological Deficit/Dysfunction (1982); Tingling (2171); Dysphasia (2195); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 07/19/2013

Event Type  Injury  

Event Description

Issar, n.M., hedera, p., phibbs, f.T., konrad, p.E., neimat, j.S.Treating post-traumatic tremor with deep brain stimulation: report of five cases.Parkinsonism <(>&<)> related disorders.2013;19(12):1100-1105.Summary: post-traumatic tremor is one of the most common movement disorders resulting from severe head trauma.However, literature regarding successful deep brain stimulation (dbs) treatment is scarce, resulting in ambiguity regarding the optimal lead location.Most cases support the ventral intermediate nucleus, but there is evidence to defend dbs of the zona incerta, ventral oralis anterior/ posterior, and/or a combination of these targets.We report five patients with disabling posttraumatic tremor treated with dbs of the ventral intermediate nucleus and of the globus pallidus internus.Patients were referred to the vanderbilt movement disorders division, and surgical intervention was determined by a dbs multidisciplinary committee.Standard dbs procedure was followed.Patients 1e4 sustained severe diffuse axonal injuries.Patients 1e3 underwent unilateral ventral intermediate nucleus dbs for contralateral tremor, while patient 4 underwent bilateral ventral intermediate nucleus dbs.Patients 1e3 experienced good tremor reduction, while patient 4 experienced moderate tremor reduction with some dystonic posturing of the hands.Patient 5 had dystonic posturing of the right upper extremity with tremor of the left upper extremity.He was treated with bilateral dbs of the globus pallidus internus and showed good tremor reduction at follow-up.Unilateral or bilateral dbs of the ventral intermediate nucleus and bilateral dbs of the globus pallidus internus may be effective and safe treatment modalities for intractable post-traumatic tremor.Further studies are needed to clarify the optimal target for surgical treatment of post-traumatic tremor.Reported event: one (b)(6) male patient with deep brain stimulation (dbs) for post-traumatic tremor experienced moderate tremor reduction with some dystonic posturing of the hands.The reporter stated that the patient experienced stimulation-associated side effects including some dystonia movements of the upper extremities, gait instability, balance difficulties, paresthesias, ataxia while walking, and slurred speech.The reporter stated that the patient experienced decreased tremor control and increased impedance between six and 33 months after dbs implantation.It was noted that the patient underwent exploration and interrogation of the dbs system with replacement of the extension wires, which resulted in significantly improved tremor reduction.The patient reportedly continued to have some dystonic posturing of both hands while performing fine motor tasks.The reporter stated that the continued dystonic side effects may require consideration of additional leads in the globus pallidus internus (gpi) for increased tremor reduction.Further information has been requested; a supplemental report will be submitted if additional information is received.

Manufacturer Narrative

The actual event dates were not provided.This date is based on the date of publication of the article.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.The device was used for an off label indication.The device was used to treat post-traumatic tremor.Concomitant products: product id neu_unknown_ext, lot # unknown, product type extension; product id 3387, lot # unknown, product type lead.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: chad hedlund ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149619
• MDR Report Key: 3571891
• MDR Text Key: 4138135
• Report Number: 3007566237-2014-00141
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• 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: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2013
• 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: 00022 YR