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

Model Number 0676

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Asystole (4442)

Event Date 04/08/2024

Event Type  Injury  

Event Description

It was reported that noise oversensing and pacing inhibition was noted on this right ventricular (rv) lead.The patient experienced asystole and was hospitalized for monitoring.Technical services (ts) reviewed device data and provided troubleshooting recommendations.The patient was noted to have chronic atrial fibrillation (af), and xray confirmed that the rv tip and shocking coil was located higher than recommended.Provocation maneuvers were performed, and the noise was reproduced on the rv lead.This rv lead is expected to be replaced and returned to boston scientific for analysis.No adverse patient effects were reported.Additional information was received.Loss of capture was also noted on the rv lead.This rv lead was successfully replaced and is expected to be returned for analysis.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: 19133219
• MDR Text Key: 340480638
• Report Number: 2124215-2024-23564
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 04/18/2024

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: 0676
• Device Catalogue Number: 0676
• Device Lot Number: 512434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention