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

Model Number G173

Device Problems Connection Problem (2900); Device Sensing Problem (2917)

Patient Problems Tachycardia (2095); Asystole (4442)

Event Date 11/21/2023

Event Type  Injury  

Event Description

It was reported that this patient arrived at the hospital in asystole.Interrogation of the cardiac resynchronization therapy defibrillator (crt-d) device found atrial tachycardia was observed on the right ventricular channel.The right atrium showed sensing values great than 15mv.Reprogramming from vvi to aai, a stimulated r-wave was visible on the egm.It was presumed that the pace sense component of the df1 electrode is in the ra port, and the ra electrode is in the rv port.Surgical intervention was performed to connect the ra and rv leads into the correct ports.The device and both leads remain implanted.The device is functioning normally at this time.Besides surgical intervention, no adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: AUTOGEN
• 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: 18277380
• MDR Text Key: 329859286
• Report Number: 2124215-2023-69248
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G173
• Device Catalogue Number: G173
• Device Lot Number: 158836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention