MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE EL ICD DR; IMPLANTABLE DEVICE

Model Number D433

Device Problem Failure to Sense (1559)

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

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

Information indicates the device is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

It was reported that a right atrial (ra) lead replacement procedure was performed.A new ra lead was implanted, and data measured using a pacing system analyzer (psa) was appropriate.The new lead was connected to the existing implantable cardioverter defibrillator (icd) device.The impedance and threshold measurements, as measured using a programmer, were appropriate but there was no atrial sensing observed.The lead was disconnected from the device header port and measured again using a pacing system analyzer (psa) with appropriate results.The lead was again connected to the icd device and the lead terminal pin was confirmed to be fully and securely inserted into the device header port.Again, programmer measurements exhibited no atrial sensing.The lead was once again disconnected and reconnected to the device header port, but the condition did not improve.As a result, the icd device was explanted and replaced with an icd device of the same model number prior to pocket closure.The procedure was successfully completed.No additional adverse patient effects were reported.

• Brand Name: RESONATE EL ICD DR
• 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: 11668652
• MDR Text Key: 245492607
• Report Number: 2124215-2021-06547
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526588075
• UDI-Public: 00802526588075
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P960040/S385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2021

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: 01/08/2022
• Device Model Number: D433
• Device Catalogue Number: D433
• Device Lot Number: 576418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR