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

Model Number G124

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081); Over-Sensing (1438); Battery Problem (2885); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d), implanted with another manufacturer's left ventricular (lv) lead, exhibited atrial fibrillation (af) oversensing and loss of capture (loc) up to 6v@1ms.The field representative noted that lv thresholds have been chronically high.Technical services (ts) reviewed possible causes, and remote monitoring data revealed that the observed af was new as of (b)(6) 2023.It was also noted that the lv lead was likely in a basal/anterior position, which likely contributed to the atrial fibrillation (af) oversensing.Technical services (ts) reviewed troubleshooting options.The lv lead was reprogrammed to a different vector/output and lv sensing was turned off.This crt-d system remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d), implanted with another manufacturer's left ventricular (lv) lead, exhibited atrial fibrillation (af) oversensing and loss of capture (loc) up to 6v@1ms.The field representative noted that lv thresholds have been chronically high.Technical services (ts) reviewed possible causes, and remote monitoring data revealed that the observed af was new as of may 2023.It was also noted that the lv lead was likely in a basal/anterior position, which likely contributed to the atrial fibrillation (af) oversensing.Technical services (ts) reviewed troubleshooting options.The lv lead was reprogrammed to a different vector/output and lv sensing was turned off.This crt-d system remains in service.No adverse patient effects were reported.Additional information received reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) was suspected to be depleting prematurely, and a request was made to have data from this device analyzed.Data analysis indicated the battery appeared to be depleting normally, and the elevated power consumption was due to sensing of high atrial rates.This crt-d 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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17248207
• MDR Text Key: 318297608
• Report Number: 2124215-2023-34514
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• UDI-Public: 00802526589102
• 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,Followup
• Report Date: 11/03/2023

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: 10/11/2021
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 496586
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 11/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• 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: 83 YR
• Patient Sex: Male