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

Model Number D433

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)

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

Event Date 03/11/2023

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this system exhibited noise and oversensing which resulted in inappropriate anti-tachycardia pacing (atp) therapy.The patient was using a battery-operated drill at the time of the event.Other previous episodes of noise were identified during the use of other power tools.The caller inquired if the patient's ablation for ventricular tachycardia (vt) could potentially be the cause of the new onset of oversensing.A boston scientific technical services consultant documented the reported clinical observations and discussed recommendations for tools and appliances found in and around home.No 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16820120
• MDR Text Key: 314055667
• Report Number: 2124215-2023-20189
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526588075
• UDI-Public: 00802526588075
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P960040/S385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2021
• Device Model Number: D433
• Device Catalogue Number: D433
• Device Lot Number: 568335
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male