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

Model Number	37602
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Loss of consciousness (2418); Shaking/Tremors (2515)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator (ins).The patient reported that on (b)(6) 2023 they noticed they were getting minor tremors on the left side of their body.When the patient checked the right ins (b)(6) with their patient programmer, they saw a screen that they thought meant the ins battery stopped working and needed to be replaced.Agent asked the patient if they saw the eos screen when they checked the right ins, but they do not remember seeing the eos screen.The patient also mentioned that they passed out in church yesterday, but they weren't sure if that was related to the dbs system.Regarding when they passed out in church yesterday, the patient stated, "my left side felt real weak and down i went." during the call, the patient kept seeing the 'poor communication' screen when they checked the right ins.However, synchronization was successful with the left ins (b)(6).For the left ins, the patient programmer indicated that therapy was on and the ins battery level was ok.The patient tried to connect to the right ins again, but they continued to see the 'poor communication' screen.The patient mentioned that they were supposed to have an appointment with their managing healthcare provider (hcp) today, but the hcp was sick and told the patient they would have to reschedule the appointment for on (b)(6)2023.The patient stated that they were not comfortable waiting that long and asked for physician listings in their area.Agent emailed the physician listings to the patient.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the patient (pt).The implant for the left side was not communicating with their remote device.They went to see their neurologist and they were able to get it working again.They told the patient to contact the manufacturer to get a new remote device.Circumstances leading to event were the patient was standing in church signing and felt light headed.Their left leg collapsed and they had to sit down.Actions taken to resolve the issue were the neurologist corrected the problem and changed their medication.The patient has been feeling ok since.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17375157
• Report Number: 3004209178-2023-13098
• Device Sequence Number: 17100549
• Product Code: MHY
• UDI-Device Identifier: 00613994761064
• UDI-Public: 00613994761064
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/21/2023
• Date Device Manufactured: 02/14/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male