MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND VIGILANT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number G247

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Failure (2484)

Event Date 08/24/2018

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

Boston scientific received information that during the procedure to implant this system, the patient experienced respiratory arrest.The patient was revived and the case was completed.The caller stated there was nothing abnormal about the procedure.Placement difficulty was experienced implanting the associated right ventricular (rv) lead; however, the lead was successfully implanted.The caller stated there was nothing abnormal about the procedure.No adverse patient effects were reported.

• Brand Name: VIGILANT
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7983785
• MDR Text Key: 124298181
• Report Number: 2124215-2018-17260
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2020
• Device Model Number: G247
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2018
• 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
• Treatment: 0292; 4677; 7740; G247
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 60 YR