MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; IMPLANTABLE DEVICE

Model Number G447

Device Problems High impedance (1291); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

No further information is available at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) emitted beeping tones.Data was reviewed by technical services (ts) in which the cause was attributed to a high out of range shock impedance measurement.Further device evaluation is expected at a future date.This device remains in service.No adverse patient effects were reported.

• Brand Name: RESONATE X4 CRT-D
• 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: 11182961
• MDR Text Key: 227558991
• Report Number: 2124215-2021-00513
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2021

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: 04/23/2022
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 237346
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2020
• 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