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

Model Number 37603

Device Problem Energy Output Problem (1431)

Patient Problems Fall (1848); Intracranial Hemorrhage (1891); Transient Ischemic Attack (2109); Loss of Vision (2139); Neck Stiffness (2434); Shaking/Tremors (2515); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 03/22/2017

Event Type  Injury  

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.

Event Description

It was reported that the morning after the patient's implantable neurostimulator (ins) was turned on for the first time (5 weeks after implant date, in march of 2017) they went to walk and it was like somebody was holding their ankles, then they fell and "went flat face on the floor." the patient stated that they fell 14 times over a period from a friday to the following tuesday.On that following tuesday, the patient said they crawled over to the door and over the chair to dial 911 because they had fallen and could not get up.The patient said they ended up with two brain bleeds and a mini stroke.The patient added that since march of 2017 when they started falling, they have fallen probably 40 more times.The patient said they only hit their head a couple of times and had some cat scans which have been clean so far, but it scares them.They mentioned they fell in the tub on saturday and hit their head, which was tough.The patient said they had to have the fire department and ambulance come to their home to get the patient out of the tub and the ambulance advised they go the hospital.The patient did not state what occurred after that.During the call, the patient mentioned that their tremors were "creeping up" and their hands were "shaking like a fool." later in the call, the patient said they were kind of at a "lull border" and their hand was still.At that time, the patient mentioned that they have no tremors in their right hand when they are in a mellow state and have no stress.The patient mentioned that they had called their healthcare provider (hcp) and told them about the falls, and hcp said, "cut the stimulator off." agent asked the patient if hcp was referring to turning off the ins, at which time the patient said they have a patient programmer which says the ins is "ok and stuff." the patient said they have not yet been able to follow up with their hcp.At the last appointment, patient declined receiving control over therapy settings.Patient believes their stimulation settings are at 1.6 or 1.7.Patient programmer showed ins was on and the battery ok during the call.Patient asked how long ins will last and agent reviewed longevity depends on usage/settings and redirected to hcp.Additional information was received from the patient that after finding out he had two brain bleeds and a mini stroke he was in the hospital for three months.Patient stated he found out his settings were at 2.5 and that was way too high.Hcp changed settings to 1.6 and the patient felt better.Patient stated he's had tremors for about the last 7 months.

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 they received the replacement patient programmer (pp) and it was working which allowed them to connect with the implant and therapy was on and okay.The patient said the last time they saw their managing hcp was sometime about a year ago, and they ere getting some tremors from time to time and settings were increased to 1.7v.The patient mentioned that at that hcp appointment the doctor had asked him if he was turning dbs off at night because the "battery wasn't using the full strength", but the patient said they don't turn therapy off at night and didn't know why the "full strength" wouldn't have been used.The patient added that the day after surgery when he was in a motel he woke up and couldn't see anything and his family member told him his eyes were "black", to which they said this was from the head gear they had drilled into his head for the dbs surgery to keep his head straight during surgery.When therapy was finally adjusted 5 weeks post implant to where the patient could sign their name and point at a target without shaking, but they regained sight eventually.The patient mentioned that because they fall a lot (pt said they had fallen 40 plus times and had hit their head, pt's back is "shot" and legs were swollen because of all the falling) and they had been in the er and the er wanted pt to have an mri but pt told them they couldn't get an mri because of their dbs device.Pt said last time they fell was last week in their bathroom and they had hit their head, that was the fall that cause pt to go to the er with er suggesting an mri.Pt said at first they didn't even know they had fallen but figured it out when they had stiffness in their neck and their back of their head hurt so bad and the nurse line told them to go to the er.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTIAL 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16627073
• MDR Text Key: 312116987
• Report Number: 3004209178-2023-04118
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2023
• Date Device Manufactured: 12/13/2016
• 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 Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male