MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G447

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Syncope (1610); Stroke/CVA (1770); Head Injury (1879)

Event Date 11/08/2019

Event Type  Injury  

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 noted that while the patient was shopping, they had a ventricular fibrillation (vf) episode and loss consciousness and hit her head on the floor.The patient was taken to the hospital where she was diagnosed with a concussion and a mini stroke.The patient is known to have vf episodes that degrade very quickly and ends up passing out and then the shock will get her out of it.Due to the quick vf degradation the patient has a five second duration.The field representative suggested to reprogram the patient's vf duration down to two and a half or one and a half seconds to help with the losing consciousness.The electrophysiologist noted that they would leave the duration as is because he does not think that lower it will help this patient at this time because she passes out so quickly.It was further noted that left ventricular (lv) therapy had been programmed off in the cardiac resynchronization therapy defibrillator (crt-d) because of the frequent vf events and they were thinking it was causing the patient to be pro-arrhythmic.Now the patient has transferred her care.During this four day hospitalization the lv lead therapy was programmed back on and there have been no further vf instances.The crt-d remains in service and no additional adverse patient effects were reported.

• Brand Name: RESONATE X4 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
• 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: 9588077
• MDR Text Key: 174945702
• Report Number: 2124215-2020-00522
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2021
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 213981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR