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

Model Number G158

Device Problems High impedance (1291); Over-Sensing (1438)

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

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition and also exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection.

Event Description

It was reported that this system exhibited a spike in pacing impedance on the atrial channel.A review of the device data identified an atrial tachycardia response (atr) episode due to oversensing which occurred due to the interaction between respiratory rate trend (rrt) and minute ventilation (mv).The caller was instructed to program rrt off.Additional troubleshooting did not elicit further oversensing.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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11042261
• MDR Text Key: 222704185
• Report Number: 2124215-2020-25293
• 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,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/18/2020

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: 08/19/2017
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 138418
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2015
• 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: 73 YR