MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; IMPLANTABLE LEAD

Model Number	0282
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); High Capture Threshold (3266)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) exhibited high out of range impedance measurements and high capture thresholds.The physician decided to have tachy set to monitor only so no inappropriate therapy occurred and also was programmed due to oversensing and pacing inhibition on the rv.Subsequently, a revision procedure was performed and the rv was surgically abandoned and replaced.The device reached elective replacement time (ert) and was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• 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: 19671498
• Report Number: 2124215-2024-41253
• Device Sequence Number: 6918118
• Product Code: NVY
• UDI-Device Identifier: 00802526431371
• UDI-Public: 00802526431371
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 12/10/2019
• Device Model Number: 0282
• Device Catalogue Number: 0282
• Device Lot Number: 419616
• 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: 06/26/2024
• Initial Report FDA Received Date: 07/03/2024
• Date Device Manufactured: 12/10/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female