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

Model Number 0293

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661)

Patient Problems Bradycardia (1751); Shock from Patient Lead(s) (3162)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that there was concerns there was undersensing and noisy signals on this right ventricular (rv) lead.Technical services (ts) reviewed the reports and stated that there was not a true vf and no undersensing.Reports showed the vf event was a result of oversensing of noisy signals.The patient received an inappropriate shock as a result of the oversensing.There was pacing inhibition, as well.The noisy signals were not able to be recreated.The source of the noise could not be determined.The lead remains in use.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE SG
• Type of Device: 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 55112-5798 ; 6515826168
• MDR Report Key: 18980509
• MDR Text Key: 338623805
• Report Number: 2124215-2024-18207
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526531255
• UDI-Public: 00802526531255
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2017
• Device Model Number: 0293
• Device Catalogue Number: 0293
• Device Lot Number: 345010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male