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

Model Number G124

Device Problems Failure to Capture (1081); High Capture Threshold (3266); Migration (4003)

Patient Problems Pericardial Effusion (3271); Syncope/Fainting (4411); Asystole (4442)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) was admitted to the hospital with a syncopal episode.A chest x ray analysis was completed and showed the crt-d had moved inferiorly, putting tension on the leads.The right ventricular (rv) lead did not capture at maximum output.A non-bsc left ventricular (lv) lead did not capture the left bundle branch, only the rv septum.The patient developed a pericardial effusion; therefore, a pericardial window procedure was completed.Afterwards, the patient underwent a lead revision, nevertheless a new rv lead was required as the initial rv lead showed mechanical difficulties while being revised.The non bsc lv lead dislodged during the procedure and patient went asystole.Cardiopulmonary resuscitation was performed for a few minutes while a temporary pacing wire was placed.The dislodged non bsc lead was removed, and a new one was placed in the high rv septum.The pocket was closed and discharged.No additional adverse patient effects were reported.

• 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: 18737220
• MDR Text Key: 335695057
• Report Number: 2124215-2024-09911
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 514612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female