MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Unintended Collision (1429); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Memory Loss/Impairment (1958); Muscular Rigidity (1968); Complaint, Ill-Defined (2331); Dyskinesia (2363); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for movement disorders.It was reported they were to check the placement of the leads as programming hasn't been found for optimal symptom improvement.It was noted the patient has had a lot of side effects.The patient was shaking/tremor and had rigidity and tightness.Also, parkinson-type walking.The first programming, the hcp could have set too high, the patient was great at first then in 10 days they had dyskinesia.Right after programming, the patient was high-stepping and walking real fast.The second reprogramming, about 10 days after the first one.The patient had mental confusion, memory/concentration issues, and hands were shooting out and legs kicked out.The patient fell a couple times.The patient went in every two weeks and the improvement would only last a day or two and then the voice became "sing songy" and the patient wasn't thinking right and their eyes became shiny.The patient ended up going to a new hcp and it still hasn't worked.The new hcp recommended potentially adding leads shortly after seeing the patient, and during that time, their voice became so "sing songy" and their walk was really unstable and the patient was kicking out a lot and their concentration was really bad.The patient saw this hcp 3 times since (b)(6) 2017 to (b)(6) 2018.Today, the patient switched to a new hcp, who is recommending a mri and performed mapping on one side and reprogramming today.These symptoms were reported as sudden.No further complications were reported as a result of this event.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7545110
• MDR Text Key: 109508596
• Report Number: 3004209178-2018-11899
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: 05/25/2018

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 Expiration Date: 01/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 05/25/2018
• Date Device Manufactured: 08/11/2017
• 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 Age: 70 YR