MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

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

Patient Problems Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 03/20/2014

Event Type  Injury  

Event Description

It was reported the patient had their second deep brain stimulator (dbs) adjusted the day prior to report and the reaction to the programming had caused the patient to have walking issues and issues with their personality.It was noted they wanted to know if the use of a digital hearing aid was okay.It was noted the personality issues were specified as they ¿did not want to live and they wanted to kill themselves.¿ it was stated the patient had gone back to their doctor¿s office on the day of report and the settings were turned back to how they were prior to the adjustment and the amplitude was also increased.It was stated the programming adjustment on the day of report had resolved the personality issues.

Manufacturer Narrative

Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer.Patient product id: 3389s-40, lot# va0bjs5, implanted: (b)(6) 2013, product type: lead.Product id: 3389s-40, lot# va0bjs5, implanted: (b)(6), product type: lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• 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: 3743947
• MDR Text Key: 20858972
• Report Number: 3004209178-2014-06488
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2014
• Date Device Manufactured: 11/01/2013
• 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): Life Threatening
• Patient Age: 00076 YR