MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G138

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609); Unexpected Therapeutic Results (1631); Under-Sensing (1661)

Patient Problem Ventricular Fibrillation (2130)

Event Date 06/18/2022

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further pertinent information be provided.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) showed and episode where anti-tachycardia pacing (atp) appears to accelerate the rhythm from the patient into ventricular fibrillation (vf).The device then delivered an electric shock that returned the patient to normal rhythm.Undersensing was also observed throughout the electrograms.Various options were discussed on how to program the crt-d in order to prevent this from happening.The crt-d remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction of h6, device codes and b5, describe event or problem fields.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further pertinent information be provided.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) showed and episode where inappropriate anti-tachycardia pacing (atp) appears to accelerate the rhythm from the patient into ventricular fibrillation (vf).The device then delivered an electric shock that returned the patient to normal rhythm.Undersensing was also observed throughout the electrograms.Various options were discussed on how to program the crt-d in order to prevent this from happening.The crt-d remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction of h6, device codes and b5, describe event or problem fields.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further pertinent information be provided.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) showed and espisode where inappropriate anti-tachycardia pacing (atp) appears to accelerate the rhythm from the patient into ventricular fibrillation (vf).The device then delivered an electric shock that returned the patient to normal rhythm.Undersensing was also observed throughout the electrograms.Various options were discussed on how to program the crt-d in order to prevent this from happening.The crt-d remains in service.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 14976867
• MDR Text Key: 295612793
• Report Number: 2124215-2022-24981
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: 00802526589188
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2022

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: 05/12/2022
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 385219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 06/20/2022; 07/27/2022
• Supplement Dates FDA Received: 07/15/2022; 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2020
• 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): Other; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male