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

Model Number 37601

Device Problems Pocket Stimulation (1463); Therapy Delivered to Incorrect Body Area (1508); Patient Device Interaction Problem (4001)

Patient Problems Visual Impairment (2138); Paresthesia (4421)

Event Type  Injury  

Event Description

It was reported that the patient would experience tingling around the implanted neurostimulator and around the lead/extension connections.Patient also stated that if they pushed on a lead wire on the head he would get double vision.The patient said he had no falls or trauma near device and the issue started just after the neurostimulator was placed. impedances tested and showed no issues.X-ray did not show any noticeable damage to lead or extension.The surgeon decided to replace the implanted neurostimulator (ins) to see if issue would resolve.The manufacturer representative reported that the ins was going to be replaced regardless of the issue, but surgeon didn¿t want to do further exploratory work.Patient stated that he no longer had double vision when he pushed on the lead wire following replacement in recovery.

Manufacturer Narrative

Concomitant products: product id: neu_unknown_ext, serial#: unknown, product type: extension.Product id: neu _unknown_lead , lot# unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown; product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer's representative (rep) that the patient and surgeon did not know which lea d or extension was the possible issue.It was clarified that the replacement was already scheduled due to normal depletion.The rep was not positive if the issue resolved or not, however, the patient stated that he thought it was resolved as he didn¿t get double vision when he pushed on the wires.The tingling experience only occurred sporadically (once every few months) so it's unknown if resolved.

Manufacturer Narrative

Continuation of d10: product id 3708660 lot# serial# (b)(6) implanted: (b)(6) 2017 explanted: product type extension product id 3389s-40 lot# va1fj6r implanted: (b)(6) 2017 product type lead product id 3708660 lot# serial# (b)(6) implanted: (b)(6) 2017 product type extension product id 3389s-40 lot# va1bphd implanted: (b)(6) 2017 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.

Manufacturer Narrative

H3: analysis of the implantable neurostimulator (nkm780725h) found insignificant anomalies and the device functionally okay.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 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: 14358188
• MDR Text Key: 291395159
• Report Number: 3004209178-2022-06050
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2019
• 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 Sex: Male
• Patient Weight: 119 KG