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

Model Number 0672

Device Problems Failure to Sense (1559); Impedance Problem (2950)

Patient Problem Bradycardia (1751)

Event Date 01/14/2021

Event Type  Injury  

Event Description

It was reported that this patient presented to the emergency room due to bradycardia.Upon device data review, a high out of range impedance measurement and loss of sensing was seen from the right ventricular (rv) lead.The physician elected to surgically cap and abandon this lead.A replacement rv lead was implanted to resolve the event.The patient was stable with no additional adverse consequences.The rv lead remains implanted, but capped and out of service.

Event Description

It was reported that this patient presented to the emergency room due to bradycardia.Upon device data review, a high out of range impedance measurement and loss of sensing was seen from the right ventricular (rv) lead.The physician elected to surgically cap and abandon this lead.A replacement rv lead was implanted to resolve the event.The patient was stable with no additional adverse effects reported.The rv lead remains implanted, but capped and out of service.

• 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
• MDR Report Key: 11788507
• MDR Text Key: 249424715
• Report Number: 2124215-2021-11614
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

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 Expiration Date: 12/21/2021
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 121387
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 08/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention