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

Model Number G125

Device Problems Signal Artifact/Noise (1036); Impedance Problem (2950)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that the physician observed noisy signals from both the right atrial (ra) and left ventricular (lv) leads.There was no evidence of over-sensing nor pacing inhibition.The patient was evaluated in-clinic, where the noise was reproducible with provocative maneuvers.Additionally, decreased pacing impedance measurements were noted from the lv lead.It was hypothesized that the ra lead insulation was damaged.Information has been requested regarding the event resolution and specific lv impedance measurements, but a response has not yet been received.At this time, the system remains implanted and no adverse patient effects were reported.The lv lead is not a boston scientific product.

Event Description

It was reported that the physician observed noisy signals from both the right atrial (ra) and left ventricular (lv) leads.There was no evidence of over-sensing nor pacing inhibition.The patient was evaluated in-clinic, where the noise was reproducible with provocative maneuvers.Additionally, decreased pacing impedance measurements were noted from the lv lead.It was hypothesized that the ra lead insulation was damaged.However, it was confirmed that no further intervention would occur.At this time, the system remains implanted and no adverse patient effects were reported.The lv lead is not a boston scientific product.

Event Description

It was reported that the physician observed noisy signals from both the right atrial (ra) and left ventricular (lv) leads.There was no evidence of over-sensing nor pacing inhibition.The patient was evaluated in-clinic, where the noise was reproducible with provocative maneuvers.Additionally, decreased pacing impedance measurements were noted from the lv lead, with 20 ohms of variation noted with movement.It was hypothesized that the ra lead insulation was damaged.However, it was confirmed that no further intervention would occur, as the right ventricular (rv) lead trends were normal and there was no evidence of loss of lv capture.The physician will re-assess the patient in three months.At this time, the system remains implanted and no adverse patient effects were reported.The lv lead is not a boston scientific product.

• 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: 18574301
• MDR Text Key: 334747748
• Report Number: 2124215-2024-03706
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

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: 07/01/2021
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 134698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 04/03/2024; Not provided
• Supplement Dates FDA Received: 04/25/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male