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

Model Number G125

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609); Unexpected Therapeutic Results (1631)

Patient Problems Ventricular Fibrillation (2130); Electric Shock (2554); Syncope/Fainting (4411)

Event Date 02/13/2022

Event Type  Injury  

Manufacturer Narrative

This investigation will be updated should further pertinent information be provided.

Event Description

It was reported that the patient passed out while driving.The patient was experiencing an atrial fibrillation (af) with rapid ventricular response for which inappropriate anti-tachycardia pacing (atp) was received.Then at one of the episodes, atp was delivered and a ventricular fibrillation (vf) was developed.The device received various shocks to terminate the rhythm.The first two electric shocks were ineffective but the last one converted the rhythm.The patient was brought to the clinic were the cardiac resynchronization therapy defibrillator (crt-d) was adjusted and the patient was put on anti-arrhythmic drugs.The patient was hospitalized for several days.The patient was told the crt-d was programmed incorrectly.The crt-d remains in service at this time.No additional adverse patient effects were reported.

Event Description

It was reported that the patient passed out while driving.The patient was experiencing an atrial fibrillation (af) with rapid ventricular response for which inappropriate anti-tachycardia pacing (atp) was received.Then at one of the episodes, atp was delivered and a ventricular fibrillation (vf) was developed.The device received various shocks to terminate the rhythm.The first two electric shocks were ineffective but the last one converted the rhythm.The patient was brought to the clinic were the cardiac resynchronization therapy defibrillator (crt-d) was adjusted and the patient was put on anti-arrhythmic drugs.The patient was hospitalized for several days.The patient was told the crt-d was programmed incorrectly.No additional adverse patient effects were reported.This crt-d remained in service until the patient passed away due to reasons unrelated to this crt-d.The device was explanted and returned for analysis.

Manufacturer Narrative

This investigation will be updated should further pertinent information be provided.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• 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: 14570431
• MDR Text Key: 293137952
• Report Number: 2124215-2022-19221
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2022
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 138606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female