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

Model Number G172

Device Problems High impedance (1291); Device Displays Incorrect Message (2591)

Patient Problem Syncope (1610)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited code 1005 which is indicative of a shock being delivered into an open circuit.A high out of range pacing impedance measurement of greater than 2000 ohms was also observed on the right atrial channel.Surgical intervention was performed to abandon the patient's right ventricular lead and insert a temporary pacing system.This crt-d remains implanted and in service.No additional adverse patient effects were reported.

• 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8852567
• MDR Text Key: 153000039
• Report Number: 2124215-2019-15590
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: G172
• Device Catalogue Number: G172
• Device Lot Number: 481023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention