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

Model Number G151

Device Problems Pacing Problem (1439); Data Problem (3196)

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

Event Date 11/17/2023

Event Type  Injury  

Event Description

It was reported that this device electrograms (egm) were flat.Technical services (ts) reviewed noting this device had been programmed to electrocautery protection mode due to a right ventricular (rv) lead issue.Ts noted the egms are flat due to sensing being off in electrocautery protection mode and that tachy therapy had been turned off.Ts noted there were previous inappropriate anti-tachycardia pacing (atp) episodes.This device and rv lead remain in service.No adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that this device electrograms (egm) were flat.Technical services (ts) reviewed noting this device had been programmed to electrocautery protection mode due to a right ventricular (rv) lead issue.Ts noted the egms are flat due to sensing being off in electrocautery protection mode and that tachy therapy had been turned off.Ts noted there were previous inappropriate anti-tachycardia pacing (atp) episodes.This device and rv lead remain in service.No adverse patient effects were reported.Additional information was received that this device was explanted.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN 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: 18640673
• MDR Text Key: 334551699
• Report Number: 2124215-2024-06226
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2019
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 119693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2017
• 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): Other
• Patient Age: 51 YR
• Patient Sex: Male