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

Model Number	0662
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Low impedance (2285)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this right ventricular (rv) lead presented to the hospital due to being in cardiac arrest.The patient was intubated and was put on a ventilator.Technical services (ts) reviewed the reports and found that the lead oversensed noisy signals in one of the ventricular episodes.There were no shocks delivered.The lead remains in use.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this right ventricular (rv) lead presented to the hospital due to being in cardiac arrest.The patient was intubated and was put on a ventilator.Technical services (ts) reviewed the reports and found that the lead oversensed noisy signals in one of the ventricular episodes.There were no shocks delivered.The lead remains in use.No additional adverse patient effects were reported.Additional information received indicates that the boston scientific representative wanted to know why there was no therapy delivered in the same reports.Ts stated that the ventricular therapy rate was programmed for higher than what the patient experienced.Ts suggested reprogramming.Additionally, ts stated that there was also intermittent t-wave or p-wave oversensing.Ts also stated that the rv pacing and shock impedances significantly decreased and returned to baseline.Ts suggested a chest x-ray for lead placement and an evaluation for the lead.The lead remains in use.No adverse patient effects were reported.

• 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: 19354842
• Report Number: 2124215-2024-30651
• Device Sequence Number: 15335458
• Product Code: LWS
• UDI-Device Identifier: 00802526592850
• UDI-Public: 00802526592850
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/22/2024
• Device Model Number: 0662
• Device Catalogue Number: 0662
• Device Lot Number: 191281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female