MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G424

Device Problems Failure to Convert Rhythm (1540); Inaccurate Synchronization (1609); Unexpected Therapeutic Results (1631)

Patient Problem Ventricular Fibrillation (2130)

Event Date 06/21/2020

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized due to ineffective therapy.Data review indicated that this patient's ventricular rhythm accelerated a monomorphic ventricular tachycardia (vt) into ventricular fibrillation (vf).Shocks were delivered and but unable to diverted the arrhythmia.On the last shock, the polarity inversion successfully terminated the arrhythmia.Additionally, chest x-ray and further testing were performed the day after showing normal measurements.Technical services recommended troubleshooting options.This device remains in service at this time.No adverse patient effects were reported.

Manufacturer Narrative

Summary of the investigation: with the available information, bsc cannot confirm the clinical observations due to lack of product return.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Device technical analysis: this device remains implanted and in service; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.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 the patient was hospitalized due to ineffective therapy.Data review indicated that this patient's ventricular rhythm accelerated a monomorphic ventricular tachycardia (vt) into ventricular fibrillation (vf).Shocks were delivered and but unable to diverted the arrhythmia.On the last shock, the polarity inversion successfully terminated the arrhythmia.Additionally, chest x-ray and further testing were performed the day after showing normal measurements.Technical services recommended troubleshooting options.Additional information was received, stating that the patient was followed-up for additional testing.The device was reprogrammed and remains in service.The physician will continue to monitor the patient closely.No adverse patient effects were reported.

• Brand Name: RESONATE CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10299779
• MDR Text Key: 199647679
• Report Number: 2124215-2020-14759
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2022
• Device Model Number: G424
• Device Catalogue Number: G424
• Device Lot Number: 497727
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1