MAUDE Adverse Event Report: IPG MFG SWITZERLAND KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7428

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fatigue (1849); Anxiety (2328); Depression (2361); Sleep Dysfunction (2517); Cognitive Changes (2551); No Code Available (3191)

Event Date 07/01/2010

Event Type  Injury  

Event Description

It was reported the patient had a major intermittent depressive episode.The patient had anhedonia, worsened mood, disappointed thoughts, suicidal thoughts, sleeping problems and a lessened appetite.Intervention involved reprogramming.The event was noted as resolved without sequelae.Additional information reported the patient had nervousness.It was reported the patient had fatigue and was feeling tired the first days after reprogramming.No action had been taken.The event was noted as possibly related to the device and not related to the implant procedure.The event was noted as resolved without sequelae.Additional information reported reprogramming resulted in the nervousness disappearing.Additional information noted the device was reprogrammed again.See manufacturer report # 9614453-2014-01063 patient has bilateral systems implanted.

Manufacturer Narrative

Concomitant medical products: product id 7428, serial# (b)(4), implanted: 2010-(b)(6), product type implantable neurostimulator.Product id 3391-28, lot# 0203871780, implanted: 2010-(b)(6), product type lead.Product id neu_unknown, lot# 0203871798, implanted: 2010-(b)(6), product type unknown.Product id 7428, serial# (b)(4), implanted: 2010-(b)(6), product type implantable neurostimulator.(b)(4).

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3854112
• MDR Text Key: 16861129
• Report Number: 9614453-2014-01064
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2011
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2014
• Date Device Manufactured: 04/10/2010
• 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): Other