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); Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3998, lot# (b)(4) serial#, implanted: (b)(6) 2007, product type lead.Other relevant device(s) are: product id: 3998, serial/lot #: (b)(4), ubd: 05-jul-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was impla nted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that during the patient's ins replacement due to eos, all impedances were high when the patient's old lead was put into the new ins, the rep was unable to increase any amplitude or provide the patient any stimulation.A surgical replacement of the lead would occurafter covid restrictions are lifted from the hospital.No specific date was given for that.

Event Description

Patient had lead replaced yesterday by cs, (b)(6).She stated impedances were fine.Patient will be programmed this morning by (b)(6).

Manufacturer Narrative

Continuation of d10: product id 3998 lot# v044850 serial# implanted: (b)(6) 2007.Explanted: (b)(6) 2021.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.

• 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: 12471859
• MDR Text Key: 271469967
• Report Number: 3004209178-2021-13833
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000411923
• UDI-Public: 00763000411923
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 50