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

Model Number G124

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Off-Label Use (1494)

Patient Problems Cardiac Arrest (1762); Asystole (4442)

Event Date 05/16/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a cardiac arrest during a left sided rhizotomy procedure, so they had to suspend the procedure.There was a more than two seconds pause with asystole due to electromagnetic interference (emi) over sensing.The patient was checked afterwards and they were ok, so the field representative observed no lasting effects.The clinician was advised to put the patient in electrocautery mode previous to the procedure but they just put a magnet on top.The crt-p remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If additional information is provided, a supplemental report will be filled.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a cardiac arrest during a left sided rhizotomy procedure, so they had to suspend the procedure.There was a more than two seconds pause with asystole due to electromagnetic interference (emi) over sensing.The patient was checked afterwards and they were ok, so the field representative observed no lasting effects.The clinician was advised to put the patient in electrocautery mode previous to the procedure but they just put a magnet on top.The crt-p remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If additional information is provided, a supplemental report will be filled.

• Brand Name: MOMENTUM 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: 17076379
• MDR Text Key: 316660389
• Report Number: 2124215-2023-28916
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2023
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 506070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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): Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Male