MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0675

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

Patient Problems Death (1802); Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)

Event Date 10/27/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a system explant was performed due to infection with sepsis and the patient was treated with intravenous antibiotics.The patient expired a few days post-explant.This right ventricular lead has not been returned.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual evaluation of the lead was performed and was unremarkable.Analysis of the returned product is not able to provide relevant information for infection-related allegation but visual inspection found no indication the lead caused or contributed to the reported clinical observations.

Event Description

It was reported that the patient with this right ventricular (rv) lead had an infection with sepsis.The patient was treated with intravenous antibiotics.A revision was performed and the cardiac resynchronization therapy defibrillator (crt-d) along with the right atrial (ra) lead, right ventricular (rv) lead and left ventricular (lv) lead were explanted.The patient expired a few days after the explant procedure.The lead was returned for analysis.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11096863
• MDR Text Key: 224431205
• Report Number: 2124215-2020-27529
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526496981
• UDI-Public: 00802526496981
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2021
• Device Model Number: 0675
• Device Catalogue Number: 0675
• Device Lot Number: 502640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2019
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR