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

Model Number	37603
Medical Device Problem Codes	Unstable (1667); Communication or Transmission Problem (2896); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Nervous System Problem (4426); Insufficient Information (4580)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a consumer who reported recharging difficulties due to the patient¿s progressing parkinsons they also have dystonia problems where their toes are bent, and they cannot unbend them.It was mentioned when the patient is tired their left side shoulder slopes down and is not level, so the left side was difficult to charge resulting in only getting a good connection sometimes with receiving a message about this resulting in it taking a longer time to connect, the right chest stimulator charges fine.The patient met with a manufacturer¿s representative (rep) who confirmed a good connection with their equipment and reviewed some best recharging practices.The consumer said following a health issue the staff at the hcp office told them, something happened during the incident that caused their dbs to take "a hit" and caused their dystonia (toes/ shoulder symptoms).The staff member said the left side has an impingement on a node but it's ok because it is a node that is not needed.The consumer mentioned sometimes the patient¿s ¿brain disconnects¿ because of their parkinson¿s.
Additional Manufacturer Narrative
Section d10 references: product id: 37603, lot#serial#: (b)(6), implanted: on (b)(6) 2018, product type: implantable neurostmulator.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21547216
• Report Number: 3004209178-2025-04190
• Device Sequence Number: 7856899
• Product Code: MHY
• UDI-Device Identifier: 00613994761088
• UDI-Public: 00613994761088
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: 08/28/2018
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/07/2025
• Date Device Manufactured: 02/28/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 77 YR
• Patient Sex: Male