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

Model Number	0157
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular lead exhibited noise, oversensing and pacing inhibition of over two seconds on the right ventricular channel.It was determined that this was due to electromagnetic interference (emi).Additionally anti-tachycardia pacing (atp) was inappropriately delivered.It was discussed to contact the patient in order to address the source of the emi.No changes were performed on the device.This lead remains in service.No further adverse patient effects were reported.Additional information was received detailing that the issues with the device continue to appear and myopotential oversensing was the most likely root cause and discarded the idea of emi.Further evaluation of the patient was discussed.This lead remains in service.No further adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16865146
• Report Number: 2124215-2023-21596
• Device Sequence Number: 5421196
• Product Code: LWS
• UDI-Device Identifier: 00802526531125
• UDI-Public: 00802526531125
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 05/03/2023

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: 09/05/2010
• Device Model Number: 0157
• Device Catalogue Number: 0157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2008
• 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