MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT EL ICD VR; IMPLANTABLE DEVICE

Model Number D232

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)

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

Event Date 03/09/2024

Event Type  malfunction  

Event Description

It was reported that explant indicator was reached on (b)(6) 2020 for this patient with an implantable cardioverter defibrillator (icd).Technical services reviewed device data and found there was a code 1007.The last cap reform measured 10.2 seconds.It was recommended to check the device with a programmer.Disk analysis was performed and found the end of life (eol) was triggered by the failure to charge.The cause of the long charge times is unknown.It was noted that the patient was in hospice and a magnet was placed over the device.It was noted the passed away however, the death is not related to the code 1007.The device most likely will not be returned.No adverse patient effects were reported.

• Brand Name: VIGILANT EL ICD VR
• Type of Device: IMPLANTABLE DEVICE
• 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: 18969384
• MDR Text Key: 338688940
• Report Number: 2124215-2024-17758
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526587788
• UDI-Public: 00802526587788
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D232
• Device Catalogue Number: D232
• Device Lot Number: 314304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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 Age: 80 YR
• Patient Sex: Male