MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD

Model Number 0673

Device Problem Failure to Capture (1081)

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

Event Date 04/04/2024

Event Type  malfunction  

Event Description

It was reported that during an emergency room (er) visit, the health care professional (hcp) called technical services (ts) and requested a review and evaluation of this cardiac resynchronization therapy defibrillator (crt-d) system.It was noted that the patient collapsed and was rescued using an external device.Upon review of the stored ventricular episodes, ts was able to determine that patient ventricular arrhythmia appeared to fall below the programmed therapy threshold and remained in the monitor only zone which led to the syncopal episode.Ts discussed device programming optimization options.Further review of the egm, ts noted intermittent loss of capture (loc) on the right ventricular (rv) channel and undersensing on the right atrial (ra) channel.At this time, the crt-d, ra and rv leads remain in service.No additional adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE LEAD
• 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: 19173115
• MDR Text Key: 340956516
• Report Number: 2124215-2024-24814
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592867
• UDI-Public: 00802526592867
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 215487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2023
• 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 Age: 18 YR
• Patient Sex: Male