MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT

Model Number B35200

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Impedance Problem (2950); Patient Device Interaction Problem (4001)

Patient Problems Shaking/Tremors (2515); Electric Shock (2554)

Event Date 09/18/1998

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 3387-40, serial/lot #: (b)(4), ubd: 24-jan-2005, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that since the beginning of implant in (b)(6) 1998, the patient had been complaining of zapping on her left ventral intermediate nucleus (vim).Impedance were within normal limits.The patient has a history of neck stenosis and radiculopathy and thought it was related to stenosis and radiculopathy.The zapping was not as bad but would radiate to the patient's arm.Since the patient had the right vim implanted, the zapping was getting better.However, they noted that the patient was seen yesterday for reprogramming on the left vim.X-ray and ct scan was performed and showed no kinks.The scan looked good.Impedance showed to avoid electrode 1/2.Electrode impedance were: c0: 641 ohms c1: 487 ohms c2: 504 ohms c3: 668 ohms 01: 723 ohms 02: 739 ohms 03: 1021 ohms 12: 138 ohms 13: 749 ohms 23: 749 ohms.It is unknown when these impedances started.Impedances were within normal limits at the last office visit on (b)(6) 2021.They have had no falls.The patient felt their neck snapped/popped about 2 weeks ago when she moved her neck and noticed their right hand tremor started.Within the last couple of months, the patient felt the zapping getting worse.They reprogrammed the patient and the patient is now using electrode: 0+3-.Electrode impedance was reviewed and it was suggested to retest the impedance with the patient with various neck movement.Refer to manufacturer report #2182207-2021-00683 for related device.

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 was received from a manufacturer representative (rep) reporting that a surgery has not been scheduled yet.

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 rep presumes the extension was discarded.

Event Description

The extension was the issue.A new extension was placed and the impedance issue resolved.

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 rep said he facetimes with the physician and the patient had a complaint of inconsistent therapy <(>&<)> occasional shocking sensation in right arm.They think the therapy was inconsistent because tremors would come and go.She was also getting shocking on her left side.They mentioned the possible short.The physician is going to do an exploratory surgery to find the issue.

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.

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 rep said he facetimes with the patient and clinical providers and the patient had a complaint of inconsistent therapy <(>&<)> occasional shocking sensation in right arm.They stated that in late february, the therapy became inconsistent because tremors would come and go.She experienced shocking down her right arm when she laid on her left side or turned her head to the left in a certain way.The physician had program around the 2 contacts that were "out".During troubleshooting on (b)(6), impedances were checked and the patient had high impedances on left side (contacts 1 and 2).They also suspect a short.When re-running impedances, the patient was instructed to touch her connector site in the left neck area and as soon as the patient touched the "connection" site, she presented with shocking sensation in the right arm.The physician is going to do an exploratory surgery to find the issue.If extension only, it will be replaced.If lead is the issue, a second case would be scheduled to replace the lead at a later date.

• Brand Name: PERCEPT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11713579
• MDR Text Key: 267330544
• Report Number: 3004209178-2021-06532
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/22/2021

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: 05/14/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 05/26/2021; 05/28/2021; 05/26/2021; 06/18/2021; 06/21/2021
• Supplement Dates FDA Received: 05/28/2021; 06/01/2021; 06/02/2021; 06/21/2021; 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR