MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND VITALITY 2; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number T177

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information concerning this event is being requested from the field.

Event Description

Boston scientific received information that this device was emitting tones for an unknown reason.Boston scientific technical services advised the patient see a physician about the issue.At this time the device remains implanted and in service.No adverse patient effects were reported.

Event Description

Additional information provided from the field indicated surgical intervention was performed and the device was explanted and replaced due to normal battery depletion.No adverse patient effects were reported.

Event Description

At this time no changes to the system has been made and the patient has not made any further contact with their physician.Again, the device remains implanted and in service and there were no adverse patient effects reported.

• Brand Name: VITALITY 2
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6193273
• MDR Text Key: 62967362
• Report Number: 2124215-2016-16334
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2008
• Device Model Number: T177
• Other Device ID Number: VITALITY 2 VR EL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2007
• 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: 0181; T177
• Patient Age: 56 YR