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

Model Number	0663
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited undersensing on the atrial channel.This resulted in inappropriate anti-tachycardia pacing (atp) and multiple electric shocks due to an atrial driven arrhythmia.Boston scientific technical services (ts) was consulted and discussed programming options as well as medication options.No additional adverse patient effects were reported.At this time, this device system remains in service.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited undersensing on the ventricular channel.This resulted in inappropriate anti-tachycardia pacing (atp) and multiple electric shocks due to an atrial driven arrhythmia.Boston scientific technical services (ts) was consulted and discussed programming options as well as medication options.No additional adverse patient effects were reported.At this time, this device system remains in service.
Additional Manufacturer Narrative
Corrected fields: b5 describe event or problem model and serial number of the reported lead have been corrected.

• Brand Name: RELIANCE 4-FRONT
• Common Device Name: 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: 15814679
• Report Number: 2124215-2022-47658
• Device Sequence Number: 20183986
• Product Code: LWS
• UDI-Device Identifier: 00802526592805
• UDI-Public: 00802526592805
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/22/2021
• Device Model Number: 0663
• Device Catalogue Number: 0663
• Device Lot Number: 108744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male