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 Problems Fever (1858); Unspecified Infection (1930); Swelling (2091); No Code Available (3191)

Event Date 10/24/2020

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.(b)(4).

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was explanted due to infection.The patient underwent surgical intervention to explant the device.No additional adverse patient effects were reported.The device is not expected to return.

Manufacturer Narrative

This supplemental report was filled to correct fields b5: "describe event or problem" and h6: "patient codes".At this time, the product has not been returned.Patient code 3191 captures the reportable event of surgery.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was explanted due to infection.The patient presented a fever and when checked, the pocked was swollen.The patient underwent surgical intervention to explant the device.No additional adverse patient effects were reported.The device is not expected to return.

• 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
• MDR Report Key: 11104239
• MDR Text Key: 224779840
• Report Number: 2124215-2020-25551
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/26/2022
• Device Model Number: D433
• Device Catalogue Number: D433
• Device Lot Number: 581780
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention