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

Model Number G158

Device Problem Inaccurate Synchronization (1609)

Patient Problems Syncope (1610); Bruise/Contusion (1754); Ventricular Tachycardia (2132); No Code Available (3191)

Event Date 11/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device remains in service at this time.If additional information is received, this report will be updated.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator experienced a syncopal episode and was admitted to the intensive care unit.The syncopal episode resulted in a bruise on the patient's face.Technical services (ts) reviewed the available information and observed that the device was programmed to two tachycardia therapy zones.The patient had experienced ventricular tachycardia (vt) which met detection criteria for the first zone.This first zone did not have therapy delivery programmed on.It was reported that a change in rate zones would be discussed.The patient was also noted to have had some premature ventricular contractions (pvcs).The physician programmed ventricular rate regulation (vrr) off and brady pacing to vvir 70-100 and no further pvcs were noted.It was reported that the patient improved after the device reprogramming.The physician was concerned that the vrr programming was the cause of the patients pvcs; however, ts noted vrr had been pacing as designed and that the patient had a bundle branch block, so the pvcs could have been independent of the vrr pacing.The device remains in service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN 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: 11105009
• MDR Text Key: 224748694
• Report Number: 2124215-2020-26852
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2022
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 244995
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR