MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT EL ICD VR; Implantable Cardioverter Defibrillator

Model Number	D232
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pocket Erosion (2013); Implant Pain (4561)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) stated experiencing pain after striking the implant site with a wrench.The patient also reported significant weight loss and observed that a portion of the implanted device protruded when rotating the body.Technical services (ts) referred the patient to the physician for further evaluation.To date, this icd remains in service.No adverse patient effects were reported.

• Brand Name: VIGILANT EL ICD VR
• Common Device Name: 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, E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50550300
• Report Number: 2124215-2026-45685
• Device Sequence Number: 10384157
• Product Code: LWS
• UDI-Device Identifier: 00802526587788
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/07/2025
• Device Model Number: D232
• Device Catalogue Number: D232
• Device Lot Number: 323270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male