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

Model Number 37612

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Irritation (1941); Pain (1994); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient couldn't get their ins to charge.They were only getting clear boxes and their deep brain stimulation (dbs) was off.The manufacturing representative (rep) helped the patient get better coupling and they charged for an hour, showing some battery charge.Using the patient programmer (pp) to try to turn on dbs, they received a message with a physician face on it.They tried clearing the error message, but were unable to clear it with the pp.No environmental/external/patient factors were known.The antenna locate screen was used to find a better coupling spot, which allowed them to charge.The issue was not resolved at the time of reporting.Additional information was received on (b)(6) 2019 reporting that the patient was getting a call your doctor screen but the code on the patient controller was not provided by the patient.When the patient was pushing the arrow button on the controller, it would go back to the synchronize screen and when the patient pressed the check button, it would go back to the same call your doctor screen.They asked about the screens that could be occurring for the patient.The information was reviewed with them and they will follow up with the patient.Additional information was received on (b)(6) 2019 that the patient was able to use their pp to turn the dbs back on this date.The patient stated they would continue charging their system and would let the rep know if they continued to have issues with charging or their pp.Additional information was received on (b)(6) 2019 that the patient was still having a difficult time charging.They would call patient services today to try to troubleshoot the charging system or get a new part sent to them.Additional information was received on (b)(6) 2019 by the patient.It was reported that the therapy has turned off by itself about three times, and they had to turn it back on.They said it had been getting harder to get good coupling when charging.It was confirmed there was no issue charging the ins recharger (insr).They used to be able to reposition to find the sweet spot but could not locate a good position anymore.Sometimes stopping and restarting charging would get better coupling.On the call, the insr screen confirmed charging, but they were getting zero coupling bars.The caller was transferred to repair for replacement.Additional information was received from the manufacturer representative (rep) on (b)(6) 2019.It was reported that the new charger seems to have corrected the problem.The patient stated that charging was better now that they have the new charging system.It does appear that the deep brain stimulation (dbs) turning off was because of the inability to charge the unit.However, now the patient stated that their balance seems to be off a bit.They tried lowering their setting, which helped a little.So, they turned their device off and stated that their balance is better with the device off.The patient is going to turn the device back on and see if the balance gets worse again.If so, they will reach out to their healthcare provider's (hcp's) office to see if they go in for programming.It is unknown as to why they started having balance issues all of the sudden.Additional information was received on (b)(6) 2020 from the manufacturer representative (rep).It was reported that the patient went to the emergency room (er) because of pain in the chest near the generator.The physician believes the pain could be related to bronchitis and increased coughing causing irritation to the generator.The patient also stated that they have intermittent pain usually in the mornings on in their legs.This seemed to improve once they start walking but they are concerned it is related to the deep brain stimulation (dbs).It is unknown why they are having pain but they stated it started happening (b)(6).They were told to turn their device off for a few days, if tolerable, to see if the intermittent pain he was experiencing improved or not.The patient was also instructed to contact their managing physician to get the device checked and/or reprogrammed.

Manufacturer Narrative

Product id 37751, serial# (b)(4).Product type recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep stating the patient had little programming done at the appointment.The patient did not seem to be having any more pain in legs or chest and it was believed to be unrelated to the dbs.The balance issues seemed to be improved with reprogramming and it was unknown why the balance issues occurred.It was thought that it could possibly be due to the progression of the disease.The cough seemed to be related to the bronchitis and unrelated to the device.The cough had resolved.The rep said they have no further information.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the patient believed the feelings of pain in their chest and legs were related to stress and ptsd that they had for many years prior to the dbs and was possibly unrelated to their dbs.In terms of the balance issues the patient claimed that they had balance issues before their dbs as well so the issues they were experiencing may not be related to their dbs system.They suggested to the patient that they should still follow up with their doctors to have things checked out.They were scheduled to see them at the end of february and no further information could be noted.The coughing was related to bronchitis that they developed, which had since gotten better with the help of medications.The information was confirmed with the patient as they hadn¿t been able to see their doctor yet.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9613188
• MDR Text Key: 175756386
• Report Number: 3004209178-2020-01493
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Date Device Manufactured: 12/05/2016
• 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
• Patient Age: 54 YR
• Patient Weight: 82