MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Electromagnetic Interference (1194); Overheating of Device (1437); Patient Device Interaction Problem (4001)

Patient Problems Burning Sensation (2146); Discomfort (2330); Alteration In Body Temperature (2682)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was heat/discomfort around the left side and bottom of the battery pack.Patient had an mri on january 9th, did a full system recharge on january 18th, and then had spine injections the morning of january 21st.Patient had to prone on the table during the injections so there was unusual pressure on the implant.Patient only charges their system once every 2 weeks.Rep asked the patient to turn the system off for an extended period of time to see if the symptoms go away.Patient reports that while the system is still off, they were still having burning sensations around it.Patient has an appointment with their doctor on january 23rd and asked the manufacturer's representative (rep) to be present and the rep agreed.The issue was not resolved at the time of the report.

Event Description

Additional information was received from the manufacturer representative (rep).On (b)(6), the rep met with the patient at the neurologist's office.Impedances were normal.Patient reported this was not new to them but it just felt hotter today.Patient had generated off in the morning, turned back on at 12:45, and there was no heating sensation since.Patient stated it is warm around generator on occasion and "lying down can sometimes make it worse.Patient was not visibly uncomfortable.Patient denies shocking or any other adverse side effect.Per the assessment at the doctor's office, there was no redness, swelling or signs of infection.Patient stated that they do not want a replacement unless absolutely necessary.Wants to try keeping it on for a while now that she had it off for a bit and see what happens.On january 24th, rep received a text from the patient stating that turning off the device seems to have cooled it, and that it was not even warm that morning.However it was still a mystery to her.The cause of the heating sensation was not determined.

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.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9628228
• MDR Text Key: 176298196
• Report Number: 3004209178-2020-01774
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 01/25/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 70