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

Model Number 37612

Device Problems Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892)

Patient Problems Burning Sensation (2146); Shaking/Tremors (2515); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that the patient charges their implantable neurostimulator (ins) every 4th day for about an hour and today the ins charge level was still at 100%.Patient states ins level is usually at 75% before charging on the fourth day.Patient charged anyway for an hour and it did not do the melody.Patient stated the same thing happened 4 days ago when patient charged up.The time before that patient only charged for 45 minutes and heard the melody.The time before that went over an hour without the melody.There were no recent changes to settings.Patient stated today during the end of recharging feeling vibrations in the jaw and the teeth and it was warm on the chest.Patient did not feel this before.Patient states tremors are getting worse so it needs to be charged.Agent reviewed patient is still getting full therapy and programmer is showing ins is 100% charged.Patient will try charging a little longer and see if the full charge melody is heard.Patient will monitor and call back if issue persists.

Manufacturer Narrative

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 Description

Additional information received from the consumer reported they needed to charge more frequently.The patient stated that they normally charge the ins once every 4 days, but recharging frequency has been more erratic lately.The patient mentioned that on tuesday they charged the ins when the charge level was down to 75%, but it was unclear if the patient fully charged the ins that day because they mentioned they have not been hearing the wr make the beeping tones to indicate the ins has been fully charged.The patient mentioned that they stop charging the ins if they don't hear the wr make the beeping tones in the time they expect it to.Today the patient checked the ins charge level and noticed it was already down to 75%.The patient stated that they had been charging the ins for 50 minutes before calling patient services, but they have not heard the wr make the beeping tones to indicate a fully charged ins.Agent reviewed that this was because the ins was not fully charged yet.Agent had the patient open the recharger app to explain thi s.The recharger app indicated that the ins was charging, the charge level was 100%, therapy was on, and the wr had an excellent connection with the ins.Agent reviewed that if the recharger app shows 'charging,' that means the ins has not been fully charged yet.Agent reviewed that 'fully charged' will appear in the recharger app once the ins has reached a full charge.Within 10 minutes, the wr made the beeping tones to indicate the ins was fully charged.The patient was still concerned about the erratic charge frequency, so agent redirected the patient to their hcp to further address their concerns.The patient repeated that their next appointment with their managing hcp will be on (b)(6) 2024.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19100306
• MDR Text Key: 340803884
• Report Number: 3004209178-2024-09041
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000519247
• UDI-Public: 00763000519247
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2024
• Date Device Manufactured: 04/26/2022
• 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 Sex: Female