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

Model Number 37602

Device Problems Unintended Collision (1429); Low impedance (2285)

Patient Problems Twitching (2172); Shaking/Tremors (2515)

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id 37602 lot# serial# (b)(4), implanted: (b)(6) 2020 product type implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient began experiencing significant increase in tremor approximately 3 weeks ago and turned both batteries off resolving the increased tremor.The patient is experiencing muscle contractions of arm, chest, and face now when he tries to turn the battery on.He is unable to tolerate the device being on.The patient fell in (b)(6) 2021 with a hit to his head and also on (b)(6) 2021 with a hit to his forehead that required an er visit.The patient was seen in clinic and the provider turned stimulation down for the left battery but the patient was still experiencing muscle contractions.The device was left off and the right device is also off.Impedances from the most recent office visit on (b)(6) 2021 were requested.The devices are currently off until further evaluation can be completed.The clinic also requested the rep reach out to the patient for help obtaining a replacement remote.The issue has not been resolved.The patient's relevant medical history includes balance issues/falling.Additional information received from the manufacturer¿s representative (rep) reported the healthcare provider (hcp) tried turning down ¿v¿ level on one battery (it was unclear on which side as the hcp and patient¿s reports differed), but the problem didn¿t resolve.The hcp was no longer comfortable seeing the patient for further troubleshooting and referred them to see their neurosurgeon for further evaluation.The referral process was currently pending and was expected to take a few weeks while the rep continued to see the patient weekly for updates on appointment status.It was unknown at this time if the fall affected the device.Partial records were obtained from the hcp which indicated a short on contact 0 monopolar for the right vim system, but it wasn¿t determined if this was a new change with left impedances being normal.The cause of the new symptoms hadn¿t been determined with the device remaining off at the present time as when either device was on, the problem returned.The patient was instructed to keep the device off until further troubleshooting could be completed by the provider.

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 manufacturer¿s representative (rep) who reported the patient called their appointment and said they would call back to reschedule the appointment.

• 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: 12539305
• MDR Text Key: 273545379
• Report Number: 3004209178-2021-14479
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864207
• UDI-Public: 00643169864207
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Date Device Manufactured: 02/16/2019
• 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: 79 YR
• Patient Sex: Male