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

Model Number 0672

Device Problems Failure to Capture (1081); Failure to Read Input Signal (1581); Low impedance (2285); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead exhibited an out-of-range amplitude measurement.Additional information provided from the field indicated the rv lead also exhibited loss of capture, high threshold measurements, and a drop in pacing impedance measurements down to 307 ohms.Surgical intervention was performed, and the rv lead was explanted and replaced.No additional adverse patient effects were reported.

• 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: 19163465
• MDR Text Key: 340817351
• Report Number: 2124215-2024-24506
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 221167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention