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

Model Number DTBB1Q1

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

Patient Problems Endocarditis (1834); Fever (1858); Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Pneumonia (2011); Sepsis (2067); Pericardial Effusion (3271); Thrombocytopenia (4431); Renal Impairment (4499); Drug Resistant Bacterial Infection (4553)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: 429888 lead, implanted (b)(6) 2016.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.

Event Description

It was reported that the patient presented with a fever and was found to have septicemia/sepsis and was diagnosed with multiple organ dysfunction, methicillin-resistant staphylococcus aureus, bacteremia, thrombocytopenia and infective endocarditis.A transesophageal echocardiogram (tee) was performed and showed evidence of vegetation on one of the leads.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted and the patient was treated with antibiotics and required pressor support for hypotension.The patient was noted to have a small pericardial effusion prior to the explant and there was no change post procedure.Over the course of the hospitalization the patient developed acute on chronic kidney injury resulting in dialysis and placement of a dialysis catheter.Additionally, the patient required a bronchoscopy for pneumonia and was diagnosed with respiratory syncytial virus pneumonitis.The patient was noted to have a large left pleural effusion.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.The battery indicator signifying that it is time for device replacement occurred after explant.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VIVA¿ QUAD S 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 18895561
• MDR Text Key: 337564676
• Report Number: 3004209178-2024-06994
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169530201
• UDI-Public: 00643169530201
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2018
• Device Model Number: DTBB1Q1
• Device Catalogue Number: DTBB1Q1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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: 407645 LEAD, 694758 LEAD
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 64 KG