MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0672

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Low impedance (2285); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

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

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the patient implanted with this right ventricular (rv) lead was recently seen in clinic and it was noted that loss of capture was observed.The right ventricular automatic thresholds were detected as greater than the programmed amplitude.The automatic threshold test was unable to collect data due to intrinsic beats/noise; however, the presenting electrogram shows clean artefact free channels.Additionally, the rv trend shows a sudden decrease in lead impedances from 776 ohms to 257 ohms.It was also noted that tachy mode is currently programmed to 'monitor' only.It is intended that a lead revision procedure will be performed.No adverse patient effects were reported.This lead currently remains implanted and in service.Additional information: a couple of days after the initial event notification, the field representative provided further information indicating that surgical intervention was performed to explant and replace this lead.It was also noted that a lead dislodgment occurred, which also led to high capture thresholds in addition to the other reported issues.The new implanted lead was positioned in the interventricular septum with good electrical measurements observed.There were no complications associated with the lead replacement procedure.No additional adverse patient effects were reported.This lead is not expected for return as it is currently in the possession of the hospital.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 18980514
• MDR Text Key: 338623814
• Report Number: 2124215-2024-18239
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 233051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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): Required Intervention; Hospitalization