MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7428

Device Problems Break (1069); Disconnection (1171); Unintended Collision (1429); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Seizures (2063); Seizures, Grand-Mal (2168); Complaint, Ill-Defined (2331)

Event Date 05/13/2018

Event Type  malfunction  

Manufacturer Narrative

The source literature included the following device specifics: product id neu_unknown_lead, product type lead.Product id neu_unknown_ext, product type extension.Product id neu_unknown_ext, product type extension.Product id 7428, product type implantable neurostimulator.Product id neu_unknown_lead, product type lead.Product id neu_unknown_lead, product type lead.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Summary: hippocampal deep brain stimulation (dbs) can provide an effective alternative for intractable temporal lobe epilepsy.In this case report, we describe a peculiar outcome after a post-traumatic wire-disconnection of a bilateral hippocampal dbs device.The patient presented a postoperative long-term significant reduction in seizure frequency even with an absent electric stimulation.This case gives the possibility to consider alternatives in epilepsy surgery, based on stimulation interference (lesional or electrical disturbing) in the epileptogenic zone.The following events were associated with one (b)(6) male patient with a history of epilepsy that was implanted with bilateral deep brain stimulation (dbs) hippocampal stimulation.Following an unrelated severe bladder infection with a high fever, the patient experienced a generalized tonic-clonic seizure with a fall.Consequently, the right electrode was fractured and the both of the extensions were stretched.Following the patient experiencing bronchopneumonia, which was unrelated to the device/therapy, the patient experienced a second generalized seizure with a subsequent fall.This resulted in a fracture of the left electrode, which was confirmed by an impedance measurement, a cranial x-ray, and a neck x-ray.The post-traumatic ct scan did not show any kind of contusive or hemorrhagic brain damages.Secondary to the low frequency of epileptic symptoms, the health care provider (hcp) decided on a wait-and-see solution.A post-traumatic total disconnection of the deep brain stimulation (dbs) system was reported.During the implant procedure an intraoperative x-ray control showed a mispositioning of the right electrode so the electrode was removed and replaced in the planned position.

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 7660410
• MDR Text Key: 113186868
• Report Number: 3007566237-2018-01972
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• 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: 48 YR