MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT?; Permanent Defibrillator Electrodes

Model Number	0673
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Failure to Read Input Signal (1581); Under-Sensing (1661)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a device upgrade procedure, defibrillation threshold (dft) testing was performed but was unsuccessful as the right ventricular (rv) defibrillation lead could not detect and convert.The paced qrs was 2.5mv, the induced vf was not detected and an external shock was delivered to convert the arrhythmia.The rv lead was repositioned, sensitivity was adjusted and the paced qrs was now 4.2mv.Dfts failed at 21 joules and 31 joules in the initial polarity, then was successful at 31 joules in reversed polarity.In total, 11 dfts were performed.The patient passed away over the weekend; there were no allegations against the implanted device but the physician was looking to see if any episode egms were available.Technical services discussed there was no latitude data and recommended interrogating the device post-mortem.It was noted that the patient had undergone a coronary artery bypass graft (cabg) one week before.Additional information was received confirming the device was not interrogated post-mortem and the device and lead were not explanted for return.The official cause of death was not provided to the local sales representative and the physician did not consider the device to be a contributory cause in the death.However, boston scientific is not able to rule out the prolonged procedure with multiple dfts as a contributing cause.
Additional Manufacturer Narrative
This report will be updated when our investigation is complete.

• Brand Name: RELIANCE 4-FRONT?
• Common Device Name: Permanent Defibrillator Electrodes
• 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50809993
• Report Number: 2124215-2026-49801
• Device Sequence Number: 8900200
• Product Code: NVY
• UDI-Device Identifier: 00802526592867
• UDI-Public: (01)00802526592867(17)280716
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 315593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 07/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR
• Patient Sex: Male