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

Model Number G151

Device Problems Over-Sensing (1438); Failure to Read Input Signal (1581); Under-Sensing (1661)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported that the health care professional (hcp) had called in to review the electrogram (egm) for cardiac resynchronization therapy defibrillator (crt-d).Upon review with the technical services (ts), there was low amplitude noted on the ra lead which was due to farfield oversensing.Ts discussed options for adjusting blanking and sensitivity.This device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

This report contains additional information in section b5 describe event or problem and h6 device codes.

Event Description

It was reported that the health care professional (hcp) had called in to review the electrogram (egm) for cardiac resynchronization therapy defibrillator (crt-d).Upon review with the technical services (ts), there was low amplitude noted on the ra lead which was due to farfield oversensing.Ts discussed options for adjusting blanking and sensitivity.This device remains in service.No adverse patient effects were reported.Additional information received indicated that there was undersensing on the right atrial (ra) channel as seen on the presenting.Technical services (ts) recommended to change the sensitivity and adjust blanking to address fairfield oversensing.This device remains in service.

• Brand Name: DYNAGEN 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: 17967808
• MDR Text Key: 326078373
• Report Number: 2124215-2023-58194
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/16/2020
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 126621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• 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: 87 YR
• Patient Sex: Female