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

Model Number 37612

Device Problems Electromagnetic Compatibility Problem (2927); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Muscular Rigidity (1968); Loss of consciousness (2418); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown.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

It was reported that, since the patient has had the rechargeable implantable neurostimulators (inss), probably since close to implant date, caller noticed the patient will experience a loss of awareness and "just freezes for a little bit" if they move a certain way or if something touches the inss.The caller said it is not a seizure.The caller said the patient only experiences this on their "right side going to the left side." when this happens, the caller said after a couple of seconds the patient will look straight ahead, swallow, take a deep breath, take a couple of minutes to regain their composure, and then they're okay.Caller said this can happen if the patient gets in the pool and water touches the inss, or if they are in the bathtub and a washcloth is placed on the inss.The caller added that the issue occasionally happens when the patient places the recharger antenna on the inss, but not every time.Caller wasn't sure if this issue happens as a result of something moving when the patient reaching across their chest.Caller mentioned that this issue happened a couple of times recently when the patient reached in the shopping cart to grab a shirt; the caller said they had to hold the patient so they would not go backwards.The caller noted that normally the patient just stands there and doesn't fall when this issue happens.Yesterday, caller said this issue happened when the patient picked up a 24-pack of pop and leaned over to put it in the bottom of the shopping cart.When the patient stood up, the caller said the patient had a glazed look on their face, but they were better after a few minutes passed.The caller mentioned that they video recorded this issue a couple of years ago when it happened at home, which they showed to the patient's healthcare provider (hcp).Caller noted that the patient never turns therapy off, so they aren't sure if this issue would happen when therapy is off.Caller noted that this issue seems to be more pronounced now.Caller said they mentioned this issue to the patient's hcp several times, but they're thinking the hcp does not want to do anything because the patient is doing "amazingly well" otherwise.Caller said the hcp suspects that "either the cord going into ins is not fully in, or possibly a break somewhere," but they have never done any imaging.Caller mentioned that every time the hcps checked the ins, they told the patient that everything seemed to be working correctly.Caller asked if mdt had any reports of this issue happening with other patients.Agent reviewed information regarding risks/potential adverse events that could occur post-implantation of ins, leads, and/or extensions.Patient was redirected to their hcp to further address the issue.Caller said the patient has an appointment with their hcp on thursday.

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 if ¿cold water or something bumps the battery they had an episode where they were unaware and non-responsive for a few seconds.¿ the consumer would sit down and if something was still touching their chest it was removed and they would swallow and take a deep breath and become aware and be fine in a couple minutes.The physician lowered the settings which mayhave helped.

• 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
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 15975961
• MDR Text Key: 307998722
• Report Number: 3004209178-2022-16384
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

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: 10/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 01/25/2023
• Date Device Manufactured: 11/17/2011
• 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
• Treatment: "SEE H10."
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 79 KG