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); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported that the patient implanted with this device had a ventricular fibrillation episode in which oversensing and pacing inhibition for 4.5 seconds were observed.Noise was evident on both the right atrial and right ventricular bipolar channels, which are both non-boston scientific leads.There were also multiple non-sustained ventricular tachycardia (nsvt) episodes and frequent premature ventricular contractions noted.The field also noted that during the nsvt episodes, there were a few extra spikes in noise seen on the electrograms.The rv impedance trend is variable, and the most recent measurement is 1300 ohms; however, during the last check the impedance was 577 ohms.The rv thresholds trends are also variable, and the ra lead appears to have stable trends.Arm maneuvers and pocket manipulation was performed which was unable to reproduce any noise.Currently, the decision has been made to adjust the sensitivity output on the device.Technical services were consulted, and review of the latitude data indicates increased variability in daily measurements on the non-bsc rv lead as noted with variability in both pace impedance as well as auto-thresholds.Programming options were discussed and recommended.It is noted that this patient is pacer dependent.This device remains implanted and in service.No adverse patient effects were reported.

Manufacturer Narrative

Should additional information become available, a supplemental report will be provided.

• 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: 18977902
• MDR Text Key: 338757016
• Report Number: 2124215-2024-18114
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2022
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 138465
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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