MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Break (1069); Energy Output Problem (1431); Environmental Compatibility Problem (2929); Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

Information was received from a patient's representative regarding an implantable neurostimulator (ins).The reason for call, was caller reported the patient had dbs for a severe movement disorder, and mentioned the patient had been in hospital for majority of life off and on prior to dbs.And once received dbs, had been hospital free without issue for years, until the right lead broke last october.The caller stated, the right lead had been replaced in january.But after replacement, the patient was having issues with the right side lead, and stated, the patient was non-verbal, but talked with sign language.And told them they were experiencing pain in their head, believed to be caused by the lead and from too much stimulation.The caller stated, the healthcare provider (hcp) had been providing different settings, which they make based off of going by the patient's movement responses as with being non-verbal.They can't describe what they are feeling unless the right questions are asked.And only adjusted the right lead that controls left side of body as they continued having problems.But the left lead that controlled right side of body was working optimally.The caller stated, they weren't sure if the lead was not working.The right settings just had not been found, but they just hadn't been able to get the same result as before the lead had broke and needed replacing.The caller stated, because of the pain, the patient had been prescribed medications to cover the pain.But they wanted to address the cause, which they believed was the dbs.To provide the patient relief as due to the pain, the patient had now been wanting to have the dbs turned off.But the patient needs the dbs on to continue therapy from left lead.The patient was redirected to their hcp to further address the issue.The caller mentioned, they had been trying to get ahold of the hcp.But tend to have difficulty with scheduling.And there is months between appointments even if a simple settings change was all that was needed.And that they believed the hcp did not have much experience with the situation.Patient services (pss) reviewed, rep request process in case manufacturer representative (rep) being present may be beneficial.Reviewed hcp could contact tech services (tss) for questions.And offered and sent physician listings as potential option as well.The caller stated, they would be reaching out to the current hcp today with the information they had gathered with plan to further address the issue.

Manufacturer Narrative

Continuation of d10: product id: 3389s-40, lot#: (b)(4), implanted: (b)(6) 2023, product type: lead.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 09-mar-2024, udi#: (b)(4).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.

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 circumstances that led to the stimulation and lead issues was having an unrelated surgery resulting in a broken lead after surgery in (b)(6) 2022.In (b)(6) 2023 the patient had surgery to replace the bad lead and should now be working, however, it wasn't helping the patient¿s movement disorder on the left side of their body and they were waiting for their neurologist to address this.The patient had intermittent discomfort when therapy was on, but the left side brain still controlled and helped the right side of the body.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 16863187
• MDR Text Key: 314661886
• Report Number: 3004209178-2023-05889
• 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,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2023
• Date Device Manufactured: 01/30/2017
• 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 Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 70 KG