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

Model Number G125

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

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis validated low voltage fault and confirmed that the voltage recently began dropping in an irregular fashion.This was suspected to be related to an internal electrical short of the battery.Device replacement and return for detailed analysis was recommended.To date, the device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

Additional information provided from the field indicated the patient was in hospice care and subsequently passed away.The patient death was unrelated to this event and there were no allegations made.The icd remains in situ in the patient and will not be explanted and/or returned for analysis.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis validated low voltage fault and confirmed that the voltage recently began dropping in an irregular fashion.This was suspected to be related to an internal electrical short of the battery.Device replacement and return for detailed analysis was recommended.To date, the device remains in service.No 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: 17920674
• MDR Text Key: 325498320
• Report Number: 2124215-2023-56518
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2020
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 130311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• 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 Age: 94 YR
• Patient Sex: Male