MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number D233

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Battery Problem (2885)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/22/2024

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) had a magnet placed on it for a procedure.It was noted that the device delivered shocks during the procedure.Additionally, there was a delayed charge time that resulted in the device reaching elective replacement indicator (eri).The device was able to be taken out of eri.Technical services (ts) performed a data analysis and stated that the delayed charge times were due to intermittent magnet sensing and exposure to the magnetic field.The analysis revealed the battery status is normal, but the programmer latched onto the date eri was declared.Ts stated that it may be difficult to monitor battery status as a result, but the device will produce tones when eri is declared again.The device remains in use.No adverse patient effects were reported.

• Brand Name: VIGILANT EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 19154959
• MDR Text Key: 340742221
• Report Number: 2124215-2024-24312
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526587801
• UDI-Public: 00802526587801
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D233
• Device Catalogue Number: D233
• Device Lot Number: 646545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2023
• 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): Other
• Patient Age: 59 YR
• Patient Sex: Male