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

Model Number G158

Device Problems Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 03/15/2019

Event Type  malfunction  

Event Description

It was reported that during the implant procedure this cardiac resynchronization therapy defibrillator (crt-d) system exhibited far-field p-wave oversensing on the right ventricular (rv) lead.The patient experienced 4 to 5 seconds of asystole.Fluoroscopy was performed and physician thought the lead was in a good position, however, it was noted the coil wasn't completely past the tricuspid valve.Reprogramming was performed to increase the blanking and the rv sensitivity.Boston scientific technical services (ts) discussed that with increased sensitivity there is a possibility of undersensing ventricular fibrillation (vf).The physician planned to keep the patient's device programmed this way and continue to monitor.The crt-d and rv lead remain in service.No 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8512169
• MDR Text Key: 141919535
• Report Number: 2124215-2019-06653
• 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: Physician
• Type of Report: Initial
• Report Date: 04/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2019
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 173503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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 Age: 82 YR