MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	0275
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high pacing threshold 4 volts at 2 post magnetic resonance imaging (mri).A scheduled of lead extraction was planned out.Subsequently, this lead was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high pacing threshold 4 volts at 2 post magnetic resonance imaging (mri).A scheduled of lead extraction was planned out.Subsequently, this lead was explanted and replaced.No additional adverse patient effects were reported.Additional information received which indicated that the suspected caused was due to micro dislodgement.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance, visual inspection, and x ray.Measurements were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Moreover, the allegations were not confirmed basing on the normal lead resistance measurements, a passing hipot test and inspection which showed no conductor issues on sections of lead returned.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high pacing threshold 4 volts at 2 post magnetic resonance imaging (mri).A scheduled of lead extraction was planned out.Subsequently, this lead was explanted and replaced.No additional adverse patient effects were reported.Additional information received which indicated that the suspected caused was due to micro dislodgement.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 17613436
• Report Number: 2124215-2023-45754
• Device Sequence Number: 6719392
• Product Code: NVY
• UDI-Device Identifier: 00802526531224
• UDI-Public: 00802526531224
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2023

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: 10/13/2022
• Device Model Number: 0275
• Device Catalogue Number: 0275
• Device Lot Number: 421287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 09/21/2023; 10/27/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/25/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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: 80 YR
• Patient Sex: Male