MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D433

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient with this pacemaker was in the emergency department with concern of device complication.Moreover, patient had bruising and swelling since implant of the device.A chest computed tomography angiography (cta) was performed and result showed hematoma in the left chest wall surrounding the device.The patient was instructed to stop anticoagulant medication.Furthermore, patient was then prescribed with antibiotics and started pressure dressing.The device remains in service.No additional adverse patient effects were reported.

• Brand Name: RESONATE EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16881911
• MDR Text Key: 314708248
• Report Number: 2124215-2023-22066
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526588075
• UDI-Public: 00802526588075
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2023
• Device Model Number: D433
• Device Catalogue Number: D433
• Device Lot Number: 593855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male