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

Model Number	0148
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Defective Device (2588); High Capture Threshold (3266)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead oversensed noise which resulted in an inappropriate shock and anti-tachycardia pacing (atp).No asystole episode was noted.Data was sent to boston scientific technical services (ts) for their review.A follow up was schedule to perform maneuvers.At this time, the system remains in service.No adverse patient effects were reported.Data was analyzed by ts and it was concluded the noise observed is on both pace/sense and hv electrogram (egm).Normally, noise on both is an indication of some emi additional information provided by sales representative confirmed this is a only lead issue.During follow up, no changes were made.Additional information was received detailing that this lead continued to present this noise even after the device was explanted and replace due to normal battery depletion.Additionally, high pacing thresholds and high withing range pacing and shock impedance measurements were observed.Lead damage is being suspected, however at this time, it has not been confirmed.Replacement of the lead was recommended.At this time, this lead remains in service.No 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): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20039325
• Report Number: 2124215-2024-52482
• Device Sequence Number: 6537153
• Product Code: LWS
• UDI-Device Identifier: 00802526085918
• UDI-Public: 00802526085918
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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: 10/01/2005
• Device Model Number: 0148
• Device Catalogue Number: 0148
• Device Lot Number: 139658
• 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: 08/02/2024
• Initial Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 10/09/2003
• 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 Sex: Unknown