MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 7428

Device Problems Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphasia (2195); Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the patient was first implanted in 2008 and the caller stated everything was fine, but as time went on, the patient was less and less able to speak, and had difficulty making specific mouth movements with their lips and tongue.The caller stated that this speech issue was due to the electrode being too close to the "speech capital" of the patient's brain, and that electricity leads over into the "speech capital." the caller mentioned that when the dbs was turned off, the patient could speak clearly but then their tremors would return, and the caller referred to these as "violent tremors." thus, they decided it was best to keep therapy turned on to help manage the tremors.Caller mentioned that the patient has a local parkinson's support group that they are involved with and they suggested that medtronic develops a public forum for patients so they can share their experiences.The caller was wanting to share the patient's negative experience.Pss reviewed that the event in the other call code note would be reported and will have visibility downstream.

Manufacturer Narrative

Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 21-feb-2011, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: 21-feb-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14524617
• MDR Text Key: 300593566
• Report Number: 3004209178-2022-06881
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2009
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2022
• Date Device Manufactured: 03/04/2008
• 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 Sex: Male