MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; implanted subcortical electrical Stimulator (motor disorders)

Model Number 37612

Device Problems Overheating of Device (1437); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 04/01/2022

Event Type  malfunction  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that for about 6 months the implant battery was taking longer to charge up.During the call patient services (pss) had patient start an implant charging session and patient was getting 0 coupling bars.Patient said that repositioning the antenna didn't resolve poor coupling.A replacement recharger antenna will be mailed to the patient.No symptoms were reported.Therapy was on and at 25% during call.(b)(6) 2022 rtg0362519 update, rpi 365157 (con, rep): additional information received from the manufacturer¿s representative (rep) re ported the implant was still taking a long to charge with the recharger showing the implant wasn¿t charging past 50%.In addition, the consumer got a warm/burning sensation when recharging (the recharger didn¿t get hot, the patient felt it in the body).The consumer met with their healthcare provider (hcp) and nothing wrong was found, as the patient could be having als.Additional information received from the manufacturer¿s representative (rep) and consumer reported they received a replacement recharger (two days ago, but they continue to experience the burning sensation as they charge the ins as well as poor coupling (coupling bars start out as 8, then drop down to 0).Regarding the burning sensation, the patient said after a while their skin gets warm as they charge the ins and the antenna kind of sticks to their skin.The patient repeated that they have had the recharger antenna replaced multiple times prior to them getting the recharger replaced.The rep said they will contact the patient's doctor to see if they will allow them to come to the patient's next appointment.The rep said they plan on using a wr during the appointment to see if it's more effective, and might slow down the recharge rate to see if it resolves the patient's burning sensation as they charge the ins.The rep also requested to have adhesive discs shipped to the patient in the interim to see if that will help with coupling/charge efficiency.Additional information received from the consumer reported the burning sensation occurred when they put the paddle to the chest to charge.The consumer had an mri to check the device, but it still hurt.

• Brand Name: ACTIVA
• Type of Device: implanted subcortical electrical Stimulator (motor disorders)
• 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: 18147864
• MDR Text Key: 329776316
• Report Number: 3004209178-2023-21609
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2022
• Date Device Manufactured: 01/29/2016
• 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
• Treatment: "SEE H10...."
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 100 KG