MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G247

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

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067); No Code Available (3191)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.(b)(4).Device evaluated by mfr: the baseline testing completed on the device found no failing conditions.All testing completed on the device passed or was not applicable, therefore no problem was detected.

Event Description

It was reported that the patient experienced infection of the cardiac resynchronization therapy (crt-d) system.It was believed that this infection had developed from the patient's pneumonia, though the date of onset of the infection was unknown.Intravenous antibiotics were administered, and the entire system was explanted.It was planned to return the device to boston scientific; however, the leads were retained at the pathology department of the hospital.No additional adverse patient effects were reported.

Event Description

It was reported that the patient experienced infection of the cardiac resynchronization therapy (crt-d) system.It was believed that this infection had developed from the patient's pneumonia, though the date of onset of the infection was unknown.Intravenous antibiotics were administered, and the entire system was explanted.It was planned to return the device to boston scientific; however, the leads were retained at the pathology department of the hospital.No additional adverse patient effects were reported.Additional information received indicates that the patient presented with acute kidney injury (aki) and chronic obstructive pulmonary disease (copd).The patient also diagnosed with acute bronchitis, positive for influenza b, sepsis, hypoxic respiratory failure, mrsa bacteremia and left ventricular (lv) lead lead vegetation.No additional adverse patient effects were reported.

Manufacturer Narrative

B.3./d.7.: approximated based on the date the manufacturer became aware of the event.F.10.: code 3191 is for surgery.Device evaluated by mfr: this supplemental report is being filed to capture the pertinent information of a new code added to h6.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9945944
• MDR Text Key: 187200970
• Report Number: 2124215-2020-06452
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 209770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Date Manufacturer Received: 10/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR