MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO VIVA¿ XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D4

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Drug Resistant Bacterial Infection (4553)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per (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.

Event Description

It was reported that seven and a half years post cardiac resynchronization therapy defibrillator (crt-d) system implant, the patient had a small scratch on the edge of their crt-d and a raised black area over the site that was suspicious of melanoma.The patient w as subsequently seen by a dermatologist and diagnosed with malignant melanoma and at the time the extent of the melanoma was unknown.Arrangements were made to have it excised at a tertiary care center.Approximately 3 months after, the patient was admitted as the melanoma had ulcerated and was draining.A pocket infection was noted.Wound cultures came back positive for methicillin-resistant staphylococcus aureus.The patient was started on intravenous (iv) antibiotics.Four days later the patient underwent wide local excision of the melanoma, crt-d removal, and the leads were cut and capped as they could not be safely extracted.The patient was continued on iv antibiotics and had an uncomplicated recovery.A chest computerized tomography (ct) scan showed no evidence of metastasis and the patient was discharged to home.The following month the patient was seen in the office where it was determined not to replace the device system.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for correction to h10 of the previous report to reference the capa #.This regulatory report is being submitted as part of a retrospective review and remediation per d00955245 related to capa pr 564122.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: VIVA¿ XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 17756174
• MDR Text Key: 323511121
• Report Number: 3004209178-2023-15948
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007239
• UDI-Public: 00643169007239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2014
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Date Device Manufactured: 03/09/2013
• 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: 6725 ADAPTOR, 407652, LEAD, 6935M62, LEAD.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 92 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White