MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number D432

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

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

Event Date 02/24/2024

Event Type  malfunction  

Event Description

It was reported that this recently implanted implantable cardioverter defibrillator (icd) system was showing loss of capture at high capture thresholds and a right ventricular auto threshold test above programmed amplitude or suspended.Technical services (ts) recommended system evaluation.This icd system remains in service.No adverse patient effects were reported.

• Brand Name: RESONATE EL ICD VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 18841712
• MDR Text Key: 336976983
• Report Number: 2124215-2024-13548
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526588044
• UDI-Public: 00802526588044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2024

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: Lay User/Patient
• Device Model Number: D432
• Device Catalogue Number: D432
• Device Lot Number: 309675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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 Age: 27 YR
• Patient Sex: Male