MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; IMPLANTABLE DEVICE

Model Number G126

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

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

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

The return of the product was requested.If the product is returned, product investigation will be performed, and this complaint would be updated upon analysis completion.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was suspected to exhibit premature battery depletion (pbd).In addition, the device exhibited a longevity calculation from eight and a half years to one and a half years remaining.The data was sent for engineering analysis.Analysis showed that this device appears to be malfunctioning.This device was explanted.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 18854850
• MDR Text Key: 337075626
• Report Number: 2124215-2024-13994
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589140
• UDI-Public: 00802526589140
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2024
• Device Model Number: G126
• Device Catalogue Number: G126
• Device Lot Number: 106419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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: 80 YR
• Patient Sex: Male