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

Model Number G125

Device Problems Failure to Capture (1081); Pocket Stimulation (1463)

Patient Problems Device Overstimulation of Tissue (1991); Discomfort (2330)

Event Date 03/03/2024

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) was experiencing a muscle twitching sensation on their left ventricular (lv) channel.The crt-d was reprogrammed with the lv channel deactivated as the patient could not stand the discomfort of the twitching on (b)(6) 2024.Approximately one week later, the patient was reported to have passed away.Review of the crt-d data confirmed the device appropriately delivered anti-tachycardia pacing (atp) and a shock for ventricular tachycardia (vt).The vt rate morphology then fell below the shock zone, becoming functionally undersensed, and no further therapy was delivered.Boston scientific technical services (ts) confirmed that even if the vt was sensed, it would not have changed the outcome of the episode.Suspected loss of capture was also thought to have been observed on the rv shock channel, however this was refuted by ts.All evidence indicates the crt-d remains in situ.No additional 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: 18903340
• MDR Text Key: 337654494
• Report Number: 2124215-2024-15493
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 156569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR