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

Model Number 37601

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Muscle Spasm(s) (1966); Therapeutic Response, Decreased (2271)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event.Please note that this date is based off of the publication year provided as the event dates were not provided in the published literature, nor was a full publication date available in the article.It was not possible to match this event with any previously reported event.Concomitant medical products: product id: 3389, lot# unknown, product type: lead.The main component of the system.Other relevant device(s) are: product id: 3389, serial/lot #: unknown, udi#: asku.Citation: brimley c, kershenovich a.Deep brain stimulation lead migration in a child secondary to osteogenesis at the burr hole site.Interdisciplinary neurosurgery.2018;12:27-29.Doi: 10.1016/j.Inat.2017.09.009.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: the frequency of deep brain stimulation (dbs) complications is low; however, lead migration is a common way dbs therapy can become ineffective.We present a case of a (b)(6) male with generalized dystonia who underwent bilateral gpi dbs lead placement.The efficacy of the dbs system was diminished over two years and one of the leads was noted to be displaced on skull x-rays and confirmed with a head ct.During surgery to replace it, bone growth within the burr hole site was noted to have occurred and determined to be the cause for the lead migration.This is the first known case reporting osteogenesis at the burr hole site as a cause of lead migration.This complication should be kept in mind when performing dbs in children to refine a surgical technique that could prevent osteogenesis at the burr hole.Reported event: a (b)(6) male experienced increasing myoclonic activity, especially in the left side of the body, twenty-two months after implant surgery.It was thought that the dbs effectiveness had decreased.Ct scans and skull x-rays were obtained, and showed that the right dbs lead had migrated superiorly about 1 cm compared to prior (post-operative) images, out of the gpi location it had been in previously, with a new intracranial curvature close to the burr hole site.All the extracranial extensions and contacts looked unchanged compared to the prior skull x-ray images.Explorative surgery to revise the dbs lead was performed.Intraoperatively it was noticed that about 90% of the burr hole had been filled in and covered by newly formed bone, growing from deep to superficial, which explained the lead migration in the direction of the surface.The faster rate of bone growth in pediatric patients was concluded to have caused the upward migration of the lead.It was noted the inferior bony rim was removed as well as all of the exposed dura ma ter within the burr hole area at the time of initial lead placement.The authors noted they did not disregard the concept that the dura mater edges could have been involved in the new bone formation.The bone was removed with kerrison rongeurs, the old lead removed and a new lead was inserted stereotactically through a stereotactic head frame platform into the right gpi.Surgery was performed under general anesthesia.Upon follow-up, the patient's symptoms improved with an overall decrease in dystonic activity.Relevant patient medical history included secondary dystonia due to cerebral palsy, generalized severely disabling dystonic, opisthotonic like myoclonic jerks and history of prematurity, being born at (b)(6) gestation.The following device specifics were provided: lead model 3389, ins model 37601.

• Brand Name: ACTIVA
• 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: 7403010
• MDR Text Key: 104571851
• Report Number: 3007566237-2018-00994
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 04/06/2018
• 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): Required Intervention
• Patient Age: 12 YR