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

Model Number G125

Device Problems High impedance (1291); Failure to Read Input Signal (1581)

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

Event Date 02/21/2023

Event Type  malfunction  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) device exhibited a drop in the intrinsic amplitude as well as a sudden increase in the impedances on the non-boston scientific left ventricular (lv) channel.Technical services (ts) stated that the lv intrinsic amplitude has been all over the place the last year with last measurement out of range at 1.9 mv.Lv impedance measurements were around 300 ohms and then sudden increase the last few days in the 700-900 ohms.Ts also suspected that there could be loss of capture (loc).Ts recommended to have bring in the patient for further evaluation.This device and non-boston scientific lv lead remains in service.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) device exhibited a drop in the intrinsic amplitude as well as a sudden increase in the impedances on the non-boston scientific left ventricular (lv) channel.Technical services (ts) stated that the lv intrinsic amplitude has been all over the place the last year with last measurement out of range at 1.9 mv.Lv impedance measurements were around 300 ohms and then sudden increase the last few days in the 700-900 ohms.Ts also suspected that there could be loss of capture (loc).Ts recommended to have bring in the patient for further evaluation.This device and non-boston scientific lv lead remains in service.No adverse patient effects were reported.

• Brand Name: MOMENTUM CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (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: 18826612
• MDR Text Key: 336782187
• Report Number: 2124215-2024-12910
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/19/2023
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 148505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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: 77 YR
• Patient Sex: Male