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

Model Number 977006

Device Problems Break (1069); High impedance (1291); Connection Problem (2900); Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)

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

Event Date 01/03/2024

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported the ins was replaced due to normal eri.During the procedure, the hcp was unable to insert the lead any further than one electrode in the new ins. upon inspection of the lead, there was darkened discoloration down the lead where it was connected in the prime battery, and the distal tip of the lead where it connects in the battery, had some swelling and cracking.The lead could not be connect to the new ins.The surgeon then tried the other lead in the new ins and was unable to push the lead any further than one electrode in.The surgeon then attempted to insert the lead the other port on the new ins with success.At that point the surgeon said they are not using the 0¿7 port on the new battery because they were unable to pass either lead into that port.Once the lead was inserted connectivity and impedance check performed and showed all green check marks and impedances also showed all green checkmarks with impedance numbers of 40,000 on all electrodes.After removing and inserting the leads several times, still received the same green check marks yet impedance numbers of 40,000 on all electrodes.At this point the surgeon decided that they will leave the one lead in the new battery and put a plug in the other port on the new ins.The first lead was removed.The lead and ins were returned.The cause was not determined, but the issue was resolved with device removal.The rep will report additional information that becomes available.

Manufacturer Narrative

Continuation of d10: product id 3550-39.Product type accessory product id 97702 lot# serial# (b)(6).Implanted: on (b)(6) 2021.Explanted: on (b)(6) 2021.Product type implantable neurostimulator product id 3777-60.Serial# (b)(6).Implanted: on (b)(6) 2008.Explanted: on (b)(6) 2021.Product type lead product id 97702.Serial# (b)(6).Implanted: on (b)(6) 2021.Explanted: on (b)(6) 2021.Product type implantable neurostimulator section d information references the main component of the system.Other relevant device(s) are: product id: 3777-60, serial/lot #:(b)(6), ubd: 01-apr-2012, udi#: (b)(4).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
• 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: 18628067
• MDR Text Key: 334368975
• Report Number: 3004209178-2024-03205
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000411923
• UDI-Public: 00763000411923
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Date Device Manufactured: 03/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 109 KG