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

Model Number G125

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Atrial Flutter (1730)

Event Date 10/17/2018

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high out of range pacing impedance spikes on the right atrial (ra) lead, measuring greater than 2000 ohms.Noise and oversensing occurred as well.The patient's ra lead was a non-bsc product.In addition, the patient received inappropriate anti-tachycardia pacing (atp) due to atrial flutter.The rhythm alternated between a 2:1 and 3:1 conduction, which caused the right ventricular (rv) rate to become unstable.The rhythm was in the vt-1 zone and therapy for that zone was exhausted after 5 atp bursts.The device was reprogrammed and the atp bursts were increased from 5 to 10.This crt-d system remains in service.No adverse patient effects were reported.

• Brand Name: MOMENTUM 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: 8509543
• MDR Text Key: 141774486
• Report Number: 2124215-2019-04521
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589126
• UDI-Public: 00802526589126
• 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: Other
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/09/2020
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 129058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2018
• 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: 76 YR