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

Model Number G151

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Data Problem (3196)

Patient Problems Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 01/15/2024

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded an event with inappropriate shock due to electromagnetic interference (emi).The signal was of low amplitude and fast.There was noise over sensing that triggered false signal artifact monitoring events.Also, there were high, out of range measurements on both right atrial and right ventricular (rv) lead channels.Out of range impedances on both channels would suggest some type of noise interference on the leads.Patient had multiple pauses due to oversensing of this noise for more than six seconds.Presenting electrogram (egm) appeared clean with no noise present on rv or left ventricular channel.Impedances and sensing stable for all leads.The crt-d remains in service at this time.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded an event with inappropriate shock due to electromagnetic interference (emi).The signal was of low amplitude and fast.There was noise over sensing that triggered false signal artifact monitoring events.Also, there were high, out of range measurements on both right atrial and right ventricular (rv) lead channels.Out of range impedances on both channels would suggest some type of noise interference on the leads.Patient had multiple pauses due to oversensing of this noise for more than six seconds.Presenting electrogram (egm) appeared clean with no noise present on rv or left ventricular channel.Impedances and sensing stable for all leads.Additional information from the field representative confirmed that the patient had an ablation procedure on their neck.No magnet was used, and the procedure was stopped midway through.The device clinic and providers were notified.The crt-d remains in service at this time.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded an event with inappropriate shock due to electromagnetic interference (emi).The signal was of low amplitude and fast.There was noise over sensing that triggered false signal artifact monitoring events.Also, there were high, out of range measurements on both right atrial and right ventricular (rv) lead channels.Out of range impedances on both channels would suggest some type of noise interference on the leads.Patient had multiple pauses due to oversensing of this noise for more than six seconds.Presenting electrogram (egm) appeared clean with no noise present on rv or left ventricular channel.Impedances and sensing stable for all leads.Additional information from the field representative confirmed that the patient had an ablation procedure on their neck.No magnet was used, and the procedure was stopped midway through.The device clinic and providers were notified.The crt-d remains in service at this time.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18648267
• MDR Text Key: 334610631
• Report Number: 2124215-2024-06451
• Device Sequence Number: 1
• Product Code: NIK
• 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,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2019
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 121539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male