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

Model Number G126

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Failure to Convert Rhythm (1540)

Patient Problems Headache (1880); Dizziness (2194); Syncope/Fainting (4411); Asystole (4442); Implant Pain (4561)

Event Date 12/04/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system was hospitalized due to dizzy spells and episodes of syncope greater than 8 seconds.An in-hospital follow-up was performed and the device programming was adjusted.Reportedly, noise could not be reproduced.In addition, the right ventricular (rv) lead shows an increased shock impedance within normal range and the x-ray shows a sharp bending of the rv lead that may lead to intermittent noise.The crt-d also recorded loss of capture, pacing inhibition and non-conversion of ventricular arrhythmia.Further review by technical services (ts) was requested.The crt-d system remains in service.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system was hospitalized due to dizziness and light headedness with headache.The patient experienced episodes of syncope and asystole greater than 12 seconds.An in-hospital follow-up was performed and there are no arrhythmia episodes stored by the device and the right ventricular (rv) lead shows an increased shock impedance within normal range.An x-ray was performed and it shows a sharp bending of the rv lead that may lead to intermittent noise.The crt-d also recorded loss of capture, pacing inhibition and non-conversion of ventricular arrhythmia.It was mentioned that the clinic technician has identified the possible cause, and due to the patient heart condition, physical condition and age, the heart has shifted in the thoracic cavity.Therefore, the rv lead does not have enough slack to cover this position.The issue has been identified as p-wave oversensing on the rv lead and it is reproducible.The device programming was adjusted to resolve the event.Further review by technical services (ts) was performed and it was discussed that the oversensing might be related to myopotential noise as it is reproducible with higher sensitivity and while arm exercising.Further discussion on device programming and recommendations were provided.The patient was reported to be worried and angry due to the situation.The patient received latitude for remote monitoring and no further actions are planned at this time.The crt-d system remains in service.

Manufacturer Narrative

Correction: h6 field impact codes was updated.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system was hospitalized due to dizziness and light headedness with headache.The patient experienced episodes of syncope and asystole greater than 12 seconds.An in-hospital follow-up was performed and there are no arrhythmia episodes stored by the device and the right ventricular (rv) lead shows an increased shock impedance within normal range.An x-ray was performed and it shows a sharp bending of the rv lead that may lead to intermittent noise.The crt-d also recorded loss of capture, pacing inhibition and non-conversion of ventricular arrhythmia.It was mentioned that the clinic technician has identified the possible cause, and due to the patient heart condition, physical condition and age, the heart has shifted in the thoracic cavity.Therefore, the rv lead does not have enough slack to cover this position.The issue has been identified as p-wave oversensing on the rv lead and it is reproducible.The device programming was adjusted to resolve the event.Further review by technical services (ts) was performed and it was discussed that the oversensing might be related to myopotential noise as it is reproducible with higher sensitivity and while arm exercising.Further discussion on device programming and recommendations were provided.The patient was reported to be worried and angry due to the situation.The patient received latitude for remote monitoring and no further actions are planned at this time.The crt-d system remains in service.

Manufacturer Narrative

Correction: h6 field impact codes was updated.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system was hospitalized due to dizziness and light headedness with headache.The patient experienced episodes of syncope and asystole greater than 12 seconds.An in-hospital follow-up was performed and there are no arrhythmia episodes stored by the device and the right ventricular (rv) lead shows an increased shock impedance within normal range.An x-ray was performed and it shows a sharp bending of the rv lead that may lead to intermittent noise.The crt-d also recorded loss of capture, pacing inhibition and non-conversion of ventricular arrhythmia.It was mentioned that the clinic technician has identified the possible cause, and due to the patient heart condition, physical condition and age, the heart has shifted in the thoracic cavity.Therefore, the rv lead does not have enough slack to cover this position.The issue has been identified as p-wave oversensing on the rv lead and it is reproducible.The device programming was adjusted to resolve the event.Further review by technical services (ts) was performed and it was discussed that the oversensing might be related to myopotential noise as it is reproducible with higher sensitivity and while arm exercising.Further discussion on device programming and recommendations were provided.The patient was reported to be worried and angry due to the situation.The patient received latitude for remote monitoring and no further actions are planned at this time.The crt-d system remains in service.Additional information provided indicates the patient stated the crt-d device was explanted and replaced and the explanted device is being kept at the patient home.Boston scientific has made three attempts to obtain further information regarding this event, however; no response was received.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system was hospitalized due to dizziness and light headedness with headache.The patient experienced episodes of syncope and asystole greater than 12 seconds.An in-hospital follow-up was performed and there are no arrhythmia episodes stored by the device and the right ventricular (rv) lead shows an increased shock impedance within normal range.An x-ray was performed and it shows a sharp bending of the rv lead that may lead to intermittent noise.The crt-d also recorded loss of capture, pacing inhibition and non-conversion of ventricular arrhythmia.It was mentioned that the clinic technician has identified the possible cause, and due to the patient heart condition, physical condition and age, the heart has shifted in the thoracic cavity.Therefore, the rv lead does not have enough slack to cover this position.The issue has been identified as p-wave oversensing on the rv lead and it is reproducible.The device programming was adjusted to resolve the event.Further review by technical services (ts) was performed and it was discussed that the oversensing might be related to myopotential noise as it is reproducible with higher sensitivity and while arm exercising.Further discussion on device programming and recommendations were provided.The patient was reported to be worried and angry due to the situation.The patient received latitude for remote monitoring and no further actions are planned at this time.The crt-d system remains in service.Additional information provided indicates the patient stated the crt-d device was explanted and replaced and the explanted device is being kept at the patient home.Reportedly, the device was explanted due to physician discretion as the patient did not trust the device anymore even though there is no medical reason for that.The patient also complained about pain in the pocket area.

• 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: 15971860
• MDR Text Key: 305386362
• Report Number: 2124215-2022-52461
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589140
• UDI-Public: 00802526589140
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup,Followup,Followup,Followup
• Report Date: 04/13/2023

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: 05/02/2020
• Device Model Number: G126
• Device Catalogue Number: G126
• Device Lot Number: 103048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/29/2022; 01/12/2023; 03/08/2023; 03/31/2023
• Supplement Dates FDA Received: 01/05/2023; 01/12/2023; 03/29/2023; 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male