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

Model Number 0662

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); Pacing Problem (1439); Failure to Sense (1559)

Patient Problems Loss of consciousness (2418); Syncope/Fainting (4411)

Event Date 08/18/2021

Event Type  Injury  

Event Description

It was reported that the patient arrived to the emergency room due to syncope, was unconscious and was resuscitated.The physician then inserted a temporary catheter with an external stimulator.Upon review of the device system, it was noticed that the right ventricular (rv) lead was fractured and there was no pacing, no sensing, failure to capture and pacing impedance high out of range.Reportedly, the patient was swimming in the sea when experienced the syncope, therefore, the arms' movement is suspected to be the cause of the lead fracture.Subsequently, the physician implanted a new rv lead and the fractured one was surgically abandoned.The cardiac resynchronization therapy defibrillator (crt-d) was also replaced in the same surgical intervention.The patient has fully recovered and there were no additional adverse patient effects.Additional information provided indicates that the crt-d was replaced due to physician's discretion, and the serial number of the rv lead is not able to be obtained.

• 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
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12713629
• MDR Text Key: 278851065
• Report Number: 2124215-2021-28163
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2021

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: 0662
• Device Catalogue Number: 0662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention