MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D1

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

Patient Problems Dehydration (1807); Endocarditis (1834); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Unspecified Infection (1930); Pleural Effusion (2010); Sepsis (2067); Septic Shock (2068); Thrombosis/Thrombus (4440)

Event Date 02/24/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient was hypotensive, mottled, and dehydrated.The patient presented to the emergency room and was hospitalized for extracellular fluid (ecf) for hypoxia.During admission, the patient was diagnosed with septic shock.The patient experienced sepsis, bacteremia/septicemia infection, thrombus, and endocarditis.Intravenous antibiotic treatment was administered.Cultures were taken and the organism was identified as gram-positive enterococcus.A transesophageal echocardiogram (tee) showed large vegetation on the right ventricular (rv) lead in the atrium partially prolapsing into the tricuspid valve.There were clots in the atrium and vegetation on the leads.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted.The ra lead was partially removed and capped, until it was fully explanted at a later date.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.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 the patient was hypotensive, mottled, and dehydrated.The patient presented to the emergency room from their ex tended care facility and was hospitalized for hypoxia.During admission, the patient was diagnosed with septic shock.The patient experienced sepsis, bacteremia/septicemia infection, thrombus, recurrent enterococcus faecalis septicemia and enterococcus pacemaker endocarditis.Intravenous antibiotic treatment was administered.Blood cultures were taken, and the organism was identified as gram-positive enterococcus.Small bilateral effusions were observed via radiography.A computerized tomography (ct) scan was performed and noted a complete thrombosis of infrarenal abdominal aorta extending into the iliac arteries.The patient was noted to have chronic iliac artery disease.A transesophageal echocardiogram (tee) showed large vegetation on the right ventricular (rv) lead in the atrium partially prolapsing into the tricuspid valve.There were clots in the atrium and vegetation on the leads.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted.The ra lead was partially removed and capped, until it was fully explanted at a later date.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.It was further reported that the patient condition did not improve, the patient was placed on comfort care, transferred to inpatient hospice, where they later passed away.

Manufacturer Narrative

Correction: b5, h6 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.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11592850
• MDR Text Key: 245968560
• Report Number: 3004209178-2021-05196
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169720312
• UDI-Public: 00643169720312
• Combination Product (y/n): N
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2020
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 693565 LEAD, 407652 LEAD, 429688 LEAD
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 87