MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; DEFIBRILLATOR / PACEMAKER LEAD

Model Number 0675

Device Problems Over-Sensing (1438); Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Shock from Patient Lead(s) (3162); Syncope/Fainting (4411)

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that the patient with this right ventricular (rv) lead was admitted to the hospital for syncope and shocks from their implantable cardioverter defibrillator (icd).Review of an episode showed five shocks were delivered but were unsuccessful at terminating the patient's arrhythmia.Fortunately, the episode self-terminated and the patient regained 1:1 conduction.All shock impedances were within normal range.Another episode showed potentially inappropriate shock therapy for supraventricular tachycardia (svt) due to an under-sensed atrial beat.The local area field representative discussed with the health care professional (hcp) and recommended x-ray imaging to assess lead position.At this time, the hcp has elected to take no further action.No other adverse patient effects were reported.This icd system remains in service.Of note, the hcp does not suspect the patient's icd caused or contributed to the observed syncope.The hcp also suspects the non-conversion was potentially related to a patient condition.Should additional follow-up information be provided in the future, this report will be updated accordingly.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: DEFIBRILLATOR / PACEMAKER 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: 18988734
• MDR Text Key: 338734122
• Report Number: 2124215-2024-18592
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P910073/S145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0675
• Device Catalogue Number: 0675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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