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

Model Number 37612

Device Problems Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The event date is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient reported difficulty charging their implantable neurostimulator (ins) batteries with the wireless recharger (wr).The patient stated that when they first got the wr in (b)(6) of 2020 or (b)(6) of 2021, they noticed that it was "impossible" to get a good connection between the wr and ins batteries using the drape.As a result, the patient stated that they lie in bed and place the wr on their chest whenever they need to charge their ins batteries.The patient stated that this method had been working well until about a week ago, when they noticed their ins batteries were taking twice as long to charge.The patient stated that it used to take 20-30 minutes to get their ins batteries charged from 50% to full, but now it's taking 40 minutes to an hour.The patient added that they've been constantly needing to adjust the wr to get it to maintain a connection with their ins batteries.During the call, the wr briefly connected with one of the ins batteries, but then the wr made a descending beeping tone.The patient confirmed that the wr battery indicator was full (3 green squares).The patient was not able to confirm the wr error because they didn't have the recharger app installed on the handset.They tried to help the patient install the recharger app, but the handset wasn't connected to wifi and the patient didn't know their wifi password.The patient tried charging their ins battery again, but the wr made a descending beeping tone immediately.They had the patient reset the wr by pressing and holding down the power button.The troubleshooting steps that were taken on the call resolved the issue.The patient confirmed that both ins batteries were charging normally. the patient called back from registered phone number to get assistance installing the recharger app.The patient confirmed that the handset was connected to wifi.The patient opened the recharger app and initially reported seeing the 'not found - recharger' error message (the wr was turned off).The patient confirmed the wr connected to the recharger app after they powered on the wr.While the ins was charging, the patient reported seeing the 'recharger is inactive' screen and there were 2 tones that fell in pitch.The issue was resolved after the patient pressed the power button on the wr.Additional information received from the consumer on 2021-may-12 reporting they continued to have difficulties charging the implantable neurostimulator (ins) batteries with the wireless recharger.The consumer repeated information regarding the wireless recharger (wr) losing a connection from the ins batteries and how the wr would start beeping even when the patient was perfectly still.The patient mentioned the ins batteries took longer to charge as a result of the wr losing a connection from the ins batteries.The issue was resolved on may 4th when they reset the wr, but only for that charging session.There were no recent traumas or falls.The patient called back on (b)(6) 2021 stating they received the replacement equipment and are still having the same issues with charging.The cause was not known.Additional information was received from the consumer on 2021-nov-19 reporting that they are having a hard time recharging the right ins and ins is also not holding a charge/charge level goes out quickly.When recharging, the recharger keeps disconnecting.This has been going on for about 6 months and it keeps getting worse.The left side ins recharges fine and there are no issues with the left ins.The patient had a routine checkup with the nurse practitioner on oct 22 and she also had a hard time connecting with the right ins.The patient mentioned that last night, it took about 2 hours to charge ins from 50%-75%.

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.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

Additional information received from the consumer reported the cause of the difficulty charging was due to the connection continuing to break.The issue was still ongoing.

• Brand Name: ACTIVA
• Type of Device: 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: 12865987
• MDR Text Key: 285185408
• Report Number: 3004209178-2021-17538
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2021
• Date Device Manufactured: 02/07/2020
• 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: Male