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

Model Number 0676

Device Problems Failure to Read Input Signal (1581); Material Integrity Problem (2978); No Apparent Adverse Event (3189); High Capture Threshold (3266)

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

Event Date 03/21/2023

Event Type  Injury  

Event Description

It was reported that this this lead was explanted due to unknown product performance issues.No additional information is available at the moment.No additional adverse patient effects were reported.

Event Description

It was reported that this right ventricular (rv) lead was explanted due to sensing amplitude issues and elevated thresholds.The lead also appeared to be bent near the septum.No additional information is available at the moment.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information: b5.Describe event or problem.H6.Impact codes and device codes.

Event Description

It was reported that this right ventricular (rv) lead was explanted due to sensing amplitude issues and elevated thresholds.The lead also appeared to be bent near the septum.No additional information is available at the moment.No additional adverse patient effects were reported.

Manufacturer Narrative

This lead was returned to our post market quality assurance laboratory with the helix mechanism in a retracted position.Visual inspection found a bent helix, which was likely due to induced damage during the surgery procedure.Subsequent testing did not identify any product abnormalities that may have caused or contributed to the reported clinical observations.Laboratory analysis was unable to conclusively determine the root cause of the reported helix extension/retraction problems.

• Brand Name: RELIANCE 4-FRONT
• 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 ; 6515826168
• MDR Report Key: 16632168
• MDR Text Key: 312190636
• Report Number: 2124215-2023-14579
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2023
• Device Model Number: 0676
• Device Catalogue Number: 0676
• Device Lot Number: 506717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2021
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male