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

Model Number 37601

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Insufficient Information (3190)

Patient Problems Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

The event date is an estimated date, year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's implantable neurostimulator (ins) needed tweaking and wanted to help finding a closer health care provider (hcp) or someone to do remote programming.The patient mentioned that they were not sure if therapy was becoming less effective/ loss of therapeutic effect or if their tremors was progressing, because patient had a return of symptoms.They know the ins battery would need to replaced eventually, and patient goes through airport security, so patient would like the ins checked to make sure system was functioning as intended.The patient indicated that in the last 3 months therapy had worked not very well.A physician listing was sent to the patient.Additional information was received on 2020-feb-21 from a consumer.It was reported that the patient received the follow up letter but didn¿t provide specific answers to it so she could fill it out and mail it in.They again inquired about security screener considerations.The patient reiterated information regarding loss of therapy.The patient said they lost therapy on their right side and it varied from week to week stating one week it would be good and the next week it would be bad.The patient mentioned they called their doctor office but couldn¿t get in touch directly so they were wondering if there was a better way to reach them.Additional information was received from the consumer on 2020-mar-09.It was reported the patient was seeing: check device required screen.The meaning of the screen and that the screen is normal when they power on the patient programmer (pp) was reviewed with the patient.They confirmed the question was resolved through education.The patient is having tremors on their right side and feels like the implantable neurostimulator (ins) is not on.They stated it is hard to bring the spoon to their mouth.They noticed this in the last 6 months and in the last month and a half, they had noticed it more.Patient services confirmed the ins was on and okay.They were redirected to follow up with their healthcare provider (hcp) to discuss the symptoms.

Manufacturer Narrative

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

Event Description

Additional information received from the consumer reported going through airport security had no effect on their therapy, and the device had been checked to determine if it was functioning as intended.The issue with the tremors was not totally resolved as on different days it was worse than others.No further complications were anticipated.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 9821154
• MDR Text Key: 183152420
• Report Number: 3004209178-2020-05187
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

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: 02/28/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 05/08/2020
• Date Device Manufactured: 09/12/2016
• 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: 60 YR