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

Model Number 0180

Device Problem Defective Device (2588)

Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 02/21/2021

Event Type  Death  

Event Description

It was reported that the patient with this right ventricular (rv) lead expired one day after undergoing a procedure due to a lead fracture.During the lead extraction, bleeding occurred which was believed to be due to damage to the superior vena cava.Cardiac tamponade ensued and a sternotomy was performed.The lead was explanted and returned for analysis.

• Brand Name: ENDOTAK RELIANCE SG
• 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: 11823126
• MDR Text Key: 250552273
• Report Number: 2124215-2021-13866
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526531149
• UDI-Public: 00802526531149
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2011
• Device Model Number: 0180
• Device Catalogue Number: 0180
• Device Lot Number: 300073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• Date Device Manufactured: 07/14/2009
• 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: 70 YR