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

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Dysphasia (2195); Loss of consciousness (2418); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Type  Injury  

Event Description

The patient (pt) reported that this week they had a "brain shut down" where they ended up in the hospital and had no memory of their kids being there.Pt said they wanted to see a doctor for what was going on in their head.Pt asked if the dbs could cause difficulties walking, because they were having difficulties.Pt said they had broke their leg and they just took another fall and they think they broke the other leg.Now they have pain going up their back leg which may resemble an infection going to the brain. pt said their right lead doesn't go under the back side of their neck, but goes under the front side of their neck.Additionally, the leads are almost coming through the skin, almost all the way up to the top of their head.Pt said it had been about a year and a half since they've noticed their leads had moved but it was within this past week that they noticed the leads were really popping out (still under the skin) in the cold weather.Pt said they have a big "horn" on the right side of their head and a big "horn" on the left side.Pt said that they don't have problems with their teeth but every gum in their mouth is aching like a tooth ache and they think they need amoxicillin because the leads in the head were hard.Pt said they were looking for a doctor to prescribe them medication to stop the infection from going to their brain when the leads break through.Pss redirected pt to healthcare provider and reviewed physician listings.Pt said they may go to urgent care and asked if they could have an x-ray; pss reviewed x-ray guidelines.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name activa; product id 3389s-40 (lot: va2e9xl); product type: 0200-lead; implant date (b)(6) 2021; brand name activa; product id 3389s-40 (lot: va2edj6); product type: 0200-lead; implant date (b)(6) 2021; 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.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 went into the hospital on (b)(6) but has no memory being in the hospital.When they woke up they had been transported to a nursing home.The patient alleged that the hospitals " big electric doors shut off the implant," and was wondering if the dbs being off would cause them to pass out.Security gate labeling was reviewed and how it was unlikely to affect the dbs.The day before they went to the hospital they slept and did not eat.They couldn't talk and repeated how difficult it is for them to walk (they still cannot walk).They may have had a ct scan while they were in the hospital.The patient saw the hcp yesterday and no issues were found with the dbs.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 18753979
• MDR Text Key: 335933437
• Report Number: 3004209178-2024-05418
• Device Sequence Number: 1
• Product Code: PJS
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2024
• Date Device Manufactured: 01/19/2021
• 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 H11.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female