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

Model Number 7428

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2005

Event Type  Injury  

Manufacturer Narrative

Event date: 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.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Section d information references the main component of the system involved in the reported events; other applicable components are: product id neu_unknown_lead, lot# unknown, product type: lead.

Event Description

Paluzzi, a., bain, p.G., liu, x., yianni, j., kumarendran, k., aziz, t.Z.Pregnancy in dystonic women with in situ deep brain stimulators.Movement disorders.2006.21:5(695-698).Doi: 10.1002/mds.20777.Summary: in the past few years, an increasing number of dystonic patients, of both sexes, have undergone insertion of deep brain stimulators (dbs) with consistent improvement of their symptoms and enhancement of their quality of life.We describe 3 women with dystonia who, after insertion of bilateral globus pallidus internus stimulators, succeeded in conceiving and completing pregnancies, 2 of them having married.These histories illustrate the significant positive impact that dbs can have on women's social relationships.Based on this experience, we also provide an overview of some of the issues that might arise in pregnancy and during delivery in dystonic women with an in situ deep brain stimulator.Reported events: patient 1: a (b)(6) woman with bilateral deep brain stimulation (dbs) of the globus pallidus internus (gpi) for myoclonic dystonia experienced fracture and migration of the left electrode 15 months post-implant.This required an additional surgery, which was successfully carried out.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: KINETRA
• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5661218
• MDR Text Key: 45365617
• Report Number: 3007566237-2016-02023
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

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: 7428
• Device Catalogue Number: 7428
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: 04/21/2016
• Supplement Dates FDA Received: 09/22/2017
• 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: 22 YR