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

Model Number 0292

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2022

Event Type  malfunction  

Event Description

It was reported that there was some type of extra signals present on the right ventricular channel of the implantable cardioverter defibrillator (icd).The signals were sensed and led to the icd storing episodes of non-sustained ventricular tachycardia (nsvt).Since june 2022, 139 nsvt events were recorded, and it was questioned whether the patient had experienced some kind of trauma to the device implant area during that time.Technical services recommended to continue monitoring the situation every three months.Additional information received indicated that the right ventricular (rv) pace impedance measured less than 200 ohms and non-physiologic noise was observed on the rv channel.Technical services recommended continuing routine monitoring and also discussed additional lead monitoring options.The rv lead remains in service.

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18974522
• MDR Text Key: 338771328
• Report Number: 2124215-2024-17946
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/11/2014
• Device Model Number: 0292
• Device Catalogue Number: 0292
• Device Lot Number: 114989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2012
• 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: 26 YR