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

Model Number 0672

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Chest Pain (1776); Cardiac Perforation (2513); Shock from Patient Lead(s) (3162)

Event Date 03/19/2024

Event Type  Injury  

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) system visited the emergency room (er) due to symptoms of chest pain.It was also reported that during transfer from the er to cardiology for additional imaging and testing, the patient experienced delivery of inappropriate therapy that consisted of three bursts of anti-tachycardia pacing (atp) and one shock therapy.The local field representative was called to help with device interrogation.The field representative reported an attempt to document patient history but reported that the patient was partially coherent and was not a good historian.The icd device was interrogated and the presenting electrogram (egm) was reviewed.The presenting egm showed oversensing noise on the right ventricular (rv) lead.The rv lead also exhibited loss of capture (loc) and high out of range pacing and shock impedance measurements which led the physician to suspect that the lead might have a fracture.It was noted that xray imaging was performed, and the images appeared to show that the rv lead may also have perforated.It was noted that the therapy would be turned off while the patient was being monitored in the hospital.No additional adverse patient effects were reported.At this time, rv lead remains in service.

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) system visited the emergency room (er) due to symptoms of chest pain.It was also reported that during transfer from the er to cardiology for additional imaging and testing, the patient experienced delivery of inappropriate therapy that consisted of three bursts of anti-tachycardia pacing (atp) and one shock therapy.The local field representative was called to help with device interrogation.The field representative reported an attempt to document patient history but reported that the patient was partially coherent and was not a good historian.The icd device was interrogated and the presenting electrogram (egm) was reviewed.The presenting egm showed oversensing noise on the right ventricular (rv) lead.The rv lead also exhibited loss of capture (loc) and high out of range pacing and shock impedance measurements which led the physician to suspect that the lead might have a fracture.It was noted that xray imaging was performed, and the images appeared to show that the rv lead may also have perforated.It was noted that the therapy would be turned off while the patient was being monitored in the hospital.No additional adverse patient effects were reported.At this time, rv lead remains in service.Subsequently, additional information was received that reported that this right ventricular (rv) lead was explanted and replaced with a new lead.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 2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19056106
• MDR Text Key: 339551315
• Report Number: 2124215-2024-20948
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526592829
• UDI-Public: 00802526592829
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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 Expiration Date: 12/05/2021
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 119925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• 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): Hospitalization; Life Threatening; Other
• Patient Age: 65 YR
• Patient Sex: Female