MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE LEAD

Model Number 0673

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Failure to Sense (1559)

Patient Problem No Code Available (3191)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4) captures the reportable event stating that the patient had a prolonged procedure.At this time, the product has not been returned.If the product is returned, analysis will be performed and would be updated at that time should pertinent information be provided.

Event Description

It was reported that during the implant procedure, when this right ventricular (rv) lead was placed, only a flat or noisy line was seen, and no signals were retrieved from the lead.The physician tried with several new cables and a different pacing system analyzer (psa), however, this didn't resolve the issue.When the pacing mode was enabled, the pacing impedance measurements were greater than 4000 ohms.The physician decided to remove this lead and replace it.No adverse patient effects were reported.

Event Description

It was reported that during the implant procedure, when this right ventricular (rv) lead was placed, only a flat or noisy line was seen, and no signals were retrieved from the lead.The physician tried with several new cables and a different pacing system analyzer (psa), however, this didn't resolve the issue.When the pacing mode was enabled, the pacing impedance measurements were greater than 4000 ohms.The physician decided to remove this lead and replace it.No adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 captures the reportable event stating that the patient had a prolonged procedure.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 and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Laboratory testing was unable to reproduce the reported clinical observations.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported high impedances, noise, and failure to sense.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10638435
• MDR Text Key: 210200510
• Report Number: 2124215-2020-19242
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: 0673
• Device Catalogue Number: 0673
• Device Lot Number: 124358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 12/06/2020
• Supplement Dates FDA Received: 01/05/2021
• Patient Sequence Number: 1