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

Model Number DTBA1QQ

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

Patient Problems Endocarditis (1834); Fever (1858); Gangrene (1873); Unspecified Infection (1930); Sepsis (2067); Swelling (2091); Ulcer (2274)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 6935m55, product type: lead, implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency department due to a chronic foot ulcer.It was also reported that the patient had sepsis and bacteremia was observed in the right atrium and the right ventricle.A computerized tomography scan revealed necrotizing fasciitis and an echocardiogram revealed endocarditis.Blood cultures were taken and the organism was identified as (b)(6).Antibiotics were administered to the patient intravenously and the cardiac resynchronization therapy defibrillator (crt-d) system was explanted.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

(b)(4).Product event summary: the device was returned and analyzed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

It was later reported that the patient had experienced foot swelling and fever for four days prior to presenting to the emergency room and that they had a diabetic foot infection with gas gangrene caused by bacteremia.A mobile echodensity in the right atrium was attached to the right ventricular (rv) lead.The computerized tomography scan results were also corrected to report that there was in fact no evidence of necrotizing fasciitis in the patient's bilateral lower extremities.The patient receive a new device system a few days post-system extraction.

• Brand Name: VIVA QUAD 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
• 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: 10226448
• MDR Text Key: 197631181
• Report Number: 3004209178-2020-11519
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169530171
• UDI-Public: 00643169530171
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2018
• Device Model Number: DTBA1QQ
• Device Catalogue Number: DTBA1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR