MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VANTA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 977006

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Appropriate Term/Code Not Available (3191)

Patient Problem Discomfort (2330)

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient recently had implant and this new device was in the middle of their back.They said "they had to move it up in my back more, its a little uncomfortable, its gonna take some time to get used to.Patient reported they talked to their rep setting up a time to meet so they can do programming, and right when they were done talking to rep everything went off".  pt says their stimulation is what turned off and it happened when the pt was laying down, and wasn't sitting.Patient reported system error screen as well and this gave a code of: 0x53a58026 but says they were able to connect with implant again after seeing the code.Troubleshooting was unable to be performed as asked if pt has tried any other settings, and they said they have 3 different groups and only 1 setting on each group and have already tried all settings.The patient was redirected to their healthcare provider to further address the issue.  refer to (b)(4) for lead issues and (b)(4) for ins dying and was replaced.

Manufacturer Narrative

Concomitant medical products: product id: a72200, serial#: unknown, product id: 3487a-33, lot#: v098585, implanted: (b)(6) 2008, 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

A manufacturer representative reported, that there were no concerns about the implantable neurostimulator ,that was recently placed.It was reported, that the stimulation therapy issues are related to the lead, which had connection on the day that the new implantable neurostimulator was placed.The health care professional chose not to replace the leads, during placement of the new implantable neurostimulator on (b)(6) 2021.As of (b)(6) 2021, the patient is being seen for consultation for replacing the leads.

Event Description

The manufacturer representative reported that the cause of the stimulation turning off appears to be the result of high impedances on active electrodes.All electrodes available were above 10,000 ohms, and no configuration resulted in a stimulating sensation for the patient.The patient is currently being evaluated for a lead revision by her neurosurgeon.The patient's weight is approximately 210 pounds.The 0x53a58026 codes was observed; however, once acknowledged, normal use of the remote was obtained.The manufacturer representative also observed a redundant patient therapy app on the home screen of the remote.Only 1 of the apps presented the code.The other never gave a code, and the patient interface opened without issue.The manufacturer representative then deleted the "bad" app from the home screen, dn the issue has not been reported since.

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: VANTA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12325711
• MDR Text Key: 266704407
• Report Number: 3004209178-2021-12438
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000411923
• UDI-Public: 00763000411923
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 95