MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3389S-40

Device Problem Electromagnetic Interference (1194)

Patient Problems Radiation Burn (1755); Injury (2348); Fluid Discharge (2686)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator lead for essential tremor, parkinson's dual, epilepsy, and deep brain stimulation (dbs) therapy indications.It was reported that the patient was getting a re-implant of the left side system.The right side remained untouched during the course of the events.Caller reported that the patient suffered a radiation burn from mri scan during stage 1 but it doesn't appear to be near the lead end cap at all.Caller stated that some cases (including this particular one) at are performed with intra-op mri and clearpoint system to guide the lead caller stated the account uses lead end caps.Account mentioned that this is "like the 5th person" that this has happened to where patient has been burned.Caller didn't have any information on the previous events mentioned by the account and didn't even know if they were mdt leads or competitor leads.Caller stated that patient had stage 1 performed on (b)(6) 2019 and upon talking to patient today (prior to stage 2 implant), patient mentioned when they went home after stage 1, they noticed an ooze or trickle from their head, the wound scabbed over and healed and patient didn't think anything of it or report it to hcp.Today, the resident noticed the burn/wound and due to patient's history of infection, stage 2 implant was aborted.Caller stated that impedances were not checked intra-op during stage 1.Caller was unsure what the final action of the hcp was.Caller stated the account has a team looking into the issue and one speculation is that it is due to the scanner itself.No further complications were reported or anticipated.

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 was received indicating the cause of the burns has yet to be determined, but they did make the determination that it is not related to the leads.They have a few ideas about what may be causing it and are investigating those issues, but they have not definitively determined a cause.Interventions and resolution was not able to be confirmed at this time.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 9039236
• MDR Text Key: 158598831
• Report Number: 3007566237-2019-01968
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA2083N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 73