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

Model Number 37612

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Muscular Rigidity (1968); Pain (1994); Shaking/Tremors (2515); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 3389s-40, lot#: va0yq24, product type: lead.Product id: wr9200, serial#: unknown, product type: recharger.The main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 25-jun-2018, udi#: (b)(4).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 the electrode/lead came disconnected and the patient was wondering if it could be related to other issues.Patient stated lead was replaced in 2021 (during the conversation the year 2021 was brought up but replacement was in 2022) and every now and then it would hurt where the stimulator was implanted.Patient services (ps) asked if patient was speaking about getting the lead replaced or the ins? patient confirmed it was the ins.  patient states a couple months after having ins replaced, patient would feel electrical shocks when charging ins, patient would need to move head, feeling tightness when moving head, ins would move.Patient states also remembering she could hear something in her left ear.Patient states about 2-3 months ago not having tightness anymore and does not have that pain anymore.Yesterday patient had appointment with specialist and on the speaker phone was a manufacturer representative (rep).They were making sure ins was working because patient was going to need a mri.Patient states they realized that one of the circuit connectors was disconnected and patient can't have mri.Patient states the numbers were really high during the test.Primary dr is now going to schedule a ct scan.Patient states it seems like when the specialist does adjustments for the left side for some reason it triggers muscles in sciatic nerve and lower back.Patient states when all this started is about 20 min after the doctor adjusted patient.By the time patient got home it was affecting her sciatic nerve and back.Dr thought patient may need to go to physical therapy but patient said after two sessions the muscle on the sciatic nerve wouldn't soften.Patient using heating pads, ice packs, massages.Patient was able to lift left leg after being adjusted about 6 months ago.This is when patient was being adjusted for a different location when patients leg started to feel better.Patient states leaving ins off.If ins is on for more than 2 hours , patient can start to feel everything hurts again.That is why patient needs mri.Patient states turning off ins at night but then started having more issues so kept ins off.Patient states one time turning ins on and forgot to turn off and patient had a back ache.(patient can't remember when this was) pss redirected to hcp.

Manufacturer Narrative

Continuation of d10: product id 3389s-40 lot# va0yq24; product type lead; 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 from the patient who reported that they wanted to know the next steps that would be taken in regard to possible issue with the lead.The patient clarified that when they were in the healthcare provider's (hcp) office with the manufacturer's representative (rep) and the hcp, they did testing and said this one was over 8,000 points and no mris were allowed.The patient said at that appointment no matter what adjustments they made their hand tremor didn't get any better.

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 SYMPTOMS
• 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: 15455732
• MDR Text Key: 300258120
• Report Number: 3004209178-2022-12105
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• 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,Followup
• Report Date: 01/30/2023

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: 12/14/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 09/21/2022; 01/10/2023
• Supplement Dates FDA Received: 09/30/2022; 01/30/2023
• Date Device Manufactured: 01/25/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female