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

Model Number G124

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)

Patient Problems Pain (1994); Ventricular Fibrillation (2130); Electric Shock (2554)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate anti-tachycardia pacing (atp) due to sinus tachycardia.Technical services (ts) was consulted and discussed the reason the device treated was due to fast and stable high atrial rates with the presence of atrial fibrillation (af).Ts also observed that the atp accelerated the arrythmia to the ventricular fibrillation (vf) zone and the device delivered a shock to convert the patient.The crt-d was reprogrammed and remains in service.It was noted that the patient felt pain due to the inappropriate therapy.

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16953077
• MDR Text Key: 315464705
• Report Number: 2124215-2023-24850
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/05/2023
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 502750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR