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

Model Number 37601

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Therapeutic Effects, Unexpected (2099); Visual Disturbances (2140); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the patient is going to their cardiologist today and tried to turn off their deep brain stimulation (dbs) last night, but wanted to make sure the dbs is off.They stated last night, they may have "jacked up" the setting.They are not sure because their hand was shaking and stomach went into convulsion but now they feel fine.They don't want to feel that way again.They stated they got the okay from their healthcare provider (hcp) to turn the implant off for the cardiologist appointment.They will be seeing their neurologist next week.Patient services assisted the patient with using the patient programmer (pp) to check therapy status.The ins is off/ok.They reviewed setting function, how to change setting, and turning therapy off is a medical decision.It was recommended the patient to consult with their hcp's office.Troubleshooting resolved the issue.Additional information was received from the consumer on (b)(6) 2020.It was reported when they tried to turn off the stimulation, they saw a flash and their tummy, vision, hands and body started to shake.They finally got the device off.They guess they hit the right button.Additional information was received from the consumer on (b)(6) 2020 clarifying that the stomach seemed charged up and the device was an issue.Steps taken to resolve the stomach going into convulsion was they got the device off.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer reporting there was no change to programming and the circumstances that led to the symptoms was just trying to turn off the stimulator.

• 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: 10074547
• MDR Text Key: 191572384
• Report Number: 3004209178-2020-08869
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2020
• Date Device Manufactured: 09/14/2017
• 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: 68 YR
• Patient Weight: 73