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

Model Number	0262
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this recently implanted cardiac resynchronization therapy defibrillator (crt-d) system exhibited noise and oversensing on this right ventricular (rv) lead.It was believed to be due to air escaping from the header of the device.Technical services (ts) confirmed there was one episode of oversensing that resulted in inappropriate anti-tachycardia pacing (atp) therapy, bradycardia and pacing inhibition.Further system evaluation was planned.No additional adverse patient effects were reported.This rv lead remains in service.Additional information was received that confirmed the root cause of the noise was air escaping from the header of the device.It was noted no further events were reported and no future evaluation is expected.No additional adverse patient effects were reported.This rv lead remains in service.

• Brand Name: ENDOTAK RELIANCE G
• 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: 19952274
• Report Number: 2124215-2024-49620
• Device Sequence Number: 18367210
• Product Code: NVY
• UDI-Device Identifier: 00802526601828
• UDI-Public: 00802526601828
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/09/2024

1 Device was Involved in the Event

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: 06/06/2025
• Device Model Number: 0262
• Device Catalogue Number: 0262
• Device Lot Number: 100652
• 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: 07/26/2024
• Initial Report FDA Received Date: 08/09/2024
• Date Device Manufactured: 06/06/2023
• 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: 86 YR
• Patient Sex: Male