MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G138

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2023

Event Type  Injury  

Event Description

It was reported that this newly implanted cardiac resynchronization therapy defibrillator (crt-d) was suspected to have premature battery depletion (pbd) due to the high-power usage and there is one year remaining of battery life.Data analysis was performed, and there appears to be a hardware malfunction that has reduced the longevity of the battery.Device functions may be impacted, and device replacement was recommended.A replacement procedure has been scheduled for next week.At this time the crt-d remains in service.No adverse patient effects were reported.

Event Description

It was reported that this newly implanted cardiac resynchronization therapy defibrillator (crt-d) was suspected to have premature battery depletion (pbd) due to the high-power usage and there is one year remaining of battery life.Data analysis was performed, and there appears to be a hardware malfunction that has reduced the longevity of the battery.Device functions may be impacted, and device replacement was recommended.A replacement procedure has been scheduled for next week.At this time the crt-d remains in service.Received additional information the device was explanted and replaced.The device has returned for analysis.During the device revision the non-boston scientific left ventricular (lv) lead was dislodged and was unable to be repositioned.The lv lead was explanted and replaced with another non-boston scientific lead.The device and lead revision were successfully completed.Outside of the revision, no adverse patient effects were reported.

• Brand Name: MOMENTUM X4 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: 18196218
• MDR Text Key: 328837580
• Report Number: 2124215-2023-66253
• Device Sequence Number: 1
• Product Code: NIK
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 393565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2023
• 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: 76 YR