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

Model Number	37612
Medical Device Problem Codes	Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 37761 serial# (b)(6) product type recharger product id 37751 serial# unknown implanted: (b)(6) 2018 product type recharger product id fp6000s serial# unknown product type section d information references the main component of the system.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(6).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.
Event or Problem Description
It was reported that information was received from a patient's representative regarding an external device.The reason for call was caller stated that the recharger is not working and they think the charger is broken.Caller reported the recharger cord is broken as well.An email was sent to the repair department to replace the device.Caller also requested a drape.Caller was not with the patient at the time of the call.Caller said that the facility that patient lives in called into pats and was sent the wireless recharger/drape.Caller said facility doesn't know how to use equipment.Caller wasn't with new equipment but agent educated caller on how wireless recharger system works.Caller said they would have the staff at the patient's facility call for education.Facility may want medtronic representative to come out and educate.Caller said that the patient's desk top charger connector pin was broken and requested replacement.Agent emailed repair to send replacement desk top charger.Caller said they would use the legacy recharger and new desk top charger until the staff was comfortable with how to use new wireless recharger equipment.Caller said that the facility had broken the connector pin on the desk top charger before in the past and they believe that the wireless recharger will be better for the patient to use once they learn how to use it.Caller called back and reported that they did not receive the drape or the wireless recharger piece.Agent explained that a brand new kit was sent and there is a flap/divider and the wireless recharger is behind it.Email information to the caller, including a user manual for the wireless recharger.

• 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: 25440408
• Report Number: 3004209178-2026-09700
• Device Sequence Number: 10119922
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: (01)00643169529762(17)190414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 05/14/2018
• 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
• Patient Age: 56 YR
• Patient Sex: Male