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

Model Number 0293

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Failure to Select Signal (1582); Low impedance (2285); Device Sensing Problem (2917); Material Integrity Problem (2978)

Patient Problem Muscle Stimulation (1412)

Event Date 12/07/2018

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead exhibited low amplitude, noise, oversensing, pacing inhibition, and loss of capture.The patient experienced chest and pocket stimulation.It was noted the impedances had decreased from 700 ohms at implant to 601 ohms.Fluoroscopy was performed and the lead was still in the rv apex.Subsequently, a revision procedure was performed and the rv lead was explanted and replaced.There were two cuts noted in the lead body.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection revealed several cuts in the insulation through to all lumens.This type of damage is consistent with damage induced during the explant procedure.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported low amplitude, loss of capture, low impedances, noise, oversensing, and pacing inhibition.

Event Description

This supplemental report is being filed as the device evaluation was completed.

• Brand Name: ENDOTAK RELIANCE SG
• Type of Device: IMPLANTABLE DEFIBRILLATION LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8275169
• MDR Text Key: 134010766
• Report Number: 2124215-2019-00786
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526531255
• UDI-Public: 00802526531255
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/05/2020
• Device Model Number: 0293
• Device Catalogue Number: 0293
• Device Lot Number: 431961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR