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

Model Number	0275
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	08/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular lead exhibited noise, oversensing and pacing inhibition of up to seven seconds.Due to this, inappropriate episodes were stored.Additionally, high out of range impedance measurements were noted.Further evaluation of the patient was discussed.This lead remains in service.No further adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular lead exhibited noise, oversensing and pacing inhibition of up to seven seconds.Due to this, inappropriate episodes were stored.Additionally, high out of range impedance measurements were noted.Further evaluation of the patient was discussed.Additional information was received that this lead was explanted.No additional adverse patient effects were reported.Review of medical records indicate that a competitor was in charge of the replacement procedure, this lead was returned to boston scientific for analysis.Additional information was received detailing that this lead was discovered to have experienced fracture prior to the explant.
Additional Manufacturer Narrative
Additional information was added to the following fields: b5: describe event or problem field h6: device codes.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.The was returned severed approximately 155 mm from the terminal end.Only the proximal segment was returned.Testing was completed to assess lead electrical performance.Measurements throughout these tests were within normal limits.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this right ventricular lead exhibited noise, oversensing and pacing inhibition of up to seven seconds.Due to this, inappropriate episodes were stored.Additionally, high out of range impedance measurements were noted.Further evaluation of the patient was discussed.Additional information was received that this lead was explanted.No additional adverse patient effects were reported.Review of medical records indicate that a competitor was in charge of the replacement procedure, this lead was returned to boston scientific for analysis.Additional information was received detailing that this lead was discovered to have experienced fracture prior to the explant.

• 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): 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: 17669863
• Report Number: 2124215-2023-47434
• Device Sequence Number: 7105042
• Product Code: NVY
• UDI-Device Identifier: 00802526531224
• UDI-Public: 00802526531224
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/14/2024

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: 07/09/2016
• Device Model Number: 0275
• Device Catalogue Number: 0275
• Device Lot Number: 313192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 01/18/2024; Not provided
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 02/07/2024; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2014
• 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: 70 YR
• Patient Sex: Female