MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

Event date reflects the publication date of the article as event date could not be determined from the article.Concomitant medical products: product id: 3387s-40, lot# unknown, product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Darbin, o., dees, d., lammle, m., naritoku, d., torres-herman, t., martino, a.Computed tomographic method to quantify electrode lead deformation and subdural gap after lead implantation for deep brain stimulation.Journal of neuroscience methods.2018; 309: 55-59.Doi: 10.1016/j.Jneumeth.2018.08.024.Summary: deep brain stimulation is an effective treatment for movement disorders and psychiatric conditions.Intra-operative and post-operative events can result in brain tissue deformation (i.E.Subdural gaps) which may cause lead deformation and its displacement from optimal target.We developed a method to quantify postoperative lead deformation and we present two dbs cases to illustrate the phenomena of lead deformation resulting from the development of subdural gaps.We present a semi-automatic computational algorithm using computed tomography scanning with reconstruction to determine lead curvature relative to a theoretical straight lead between the skull entry site and lead tip.Subdural gap was quantified from the ct scan.In 2 patients who had leads implanted, analysis of ct scans was completed within 5 min each.The maximum deviation of the observed lead from the theoretical linear path was 1.1 and 2.6 mm, and the subdural gap was 5.5 and 9.6 ml, respectively.This is the first method allowing a comprehensive characterization of the lead deformation in situ.The computational algorithms provide a simple, semiautomatic method to characterize in situ lead curvature related to brain tissue deformation after lead placement.Event: a (b)(6) male patient implanted with unilateral (left side) globus pallidus internus (gpi) deep brain stimulation (dbs) for right-hand dystonia experienced lead curvature with maximum deviation of 1.1 mm from the theoretical linear path.Lead curvature was toward the occipital and lateral directions and had maximum curving less than 1.5 mm.The patient had subdural gap volume of 5.5 ml, computed from ct.Relevant patient medical history included right handed dystonia at (b)(6), which progressed to left hand and forearm.Patient medications included carbidopa, levodopa, trihexyphenidyl, baclofen, botulinum toxin, and cyclobenzaprine.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 8176451
• MDR Text Key: 131299597
• Report Number: 3007566237-2018-03638
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• 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: 11/21/2018
• 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 Age: 21 YR