MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; Stimulator, electrical, implanted, for essential tremor

Model Number 37603

Device Problems Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# unknown.Product type extension.Product id: 3389s-40.Product type lead section.Other relevant device(s) are: product id: 3708660, serial/lot #: unknown.Product id: 3389s-40, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a lead revision is needed for patient.The extension and neurostimulator were removed and they were leaving a defective lead implanted so they can perform mri imaging to replace lead at another time.Patient started coming to office due to intermittent therapy issues around july of last year.Every time patient was checked at the office, everything appeared to be good/okay.Today, the 0 electrode is defective and they would like to use it for programming.

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

The manufacturer's representative (rep) reported it couldn't be determined what component was the root cause of the impedance issue.

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id 3708660 lot# serial# (b)(6) product type extension product id 3389s-40 lot# va1ndya 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 received from the manufacturer¿s representative (rep) reported it was determined an explant and reimplant would be best for new therapy coverage.There was believed to be an issue with the connection between the original lead/extension due to positional changes.Upon further examination during the procedure, no visual problem could be found to confirm a ¿broken wire.¿ new leads were implanted due to disease progression.After the stage 2 procedure on (b)(6) 2022, and initial programming shortly thereafter, the problem was resolved and the patient had better therapy with no side effect as previously noted.

• 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: 14132512
• MDR Text Key: 291627653
• Report Number: 3004209178-2022-04840
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2022

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: 09/14/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 04/17/2022
• Supplement Dates Manufacturer Received: 07/28/2022; 11/29/2022
• Supplement Dates FDA Received: 07/28/2022; 11/30/2022
• Date Device Manufactured: 03/14/2018
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female