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

Model Number G125

Device Problems Over-Sensing (1438); Pacing Problem (1439); Inaccurate Synchronization (1609); Under-Sensing (1661)

Patient Problem Ventricular Tachycardia (2132)

Event Date 05/01/2020

Event Type  Injury  

Event Description

It was reported that this patient had a one to one supra-ventricular tachycardia or a fast atrial flutter.Three rounds of anti-tachycardia pacing (atp) were inappropriately delivered and the third atp accelerated the rhythm to a faster ventricular tachycardia (vt), into the ventricular fibrillation (vf) zone.One shock was delivered, and it converted both arrhythmias.During this episode, it was noted that same chamber undersensing was observed.A separate atrial tachy response (atr) episode was reviewed and the ventricle signal was oversensed on the atrial channel.The plan was to increase the vt zone to 200.Other programming optimizations were discussed with the field representative.No additional adverse patient effects were reported.This product remains in service.This report will be updated, should additional information be received.

• 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 CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10318101
• MDR Text Key: 200234783
• Report Number: 2124215-2020-15407
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2019
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 123422
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2017
• 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 Outcome(s): Life Threatening
• Patient Age: 76 YR