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

Model Number T180

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problem Atrial Tachycardia (1731)

Event Date 05/28/2009

Event Type  malfunction  

Event Description

Boston scientific received information that this device had a report of inappropriate therapies in (b)(6) 2009 due to a sinus tachycardia or supraventricular tachycardia.A review of the stored electrogram found that inappropriate antitachycardia pacing (atp)and shock therapy were delivered.There were no known or alleged adverse effects received/identified to date.Boston scientific received information that (b)(4) reviewed an episode from (b)(6) 2009.A review of the stored electrogram found that inappropriate antitachycardia pacing (atp)and shock therapy were delivered.There were no known or alleged adverse effects received/identified to date.The available evidence indicates that the device remains implanted and in service.Subsequently, boston scientific received information that this patient was presented back to the electrophysiology laboratory in (b)(6) 2014.The device was electively explanted and replaced due to normal battery depletion.The device was received at boston scientific's return products department.

Manufacturer Narrative

(b)(4).Upon receipt in our post market quality assurance laboratory, the device was interrogated by boston scientific's quality assurance laboratory and was found with a battery status indicator of end-of-life (eol) at 2.57 volts.Visual inspection noted that the device header was loose but had not separated from the device case.The device did not have good adhesion to the header.Additionally, tool marks were identified on the casing.An x-ray of the device verified that the feed-thru wires were stretched but not separated.The device passed manual therapy verification testing on the bench.The device was put through and passed manual diagnostic testing that verified the performance of pacing, sensing and shocking function of the device.The recorded pacing and shock impedance measurements were within normal limits.Manufacturing enhancements have been implemented to make the header bond more robust.

• Brand Name: VITALITY
• 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 55112 ; 6515824786
• MDR Report Key: 4139043
• MDR Text Key: 4929961
• Report Number: 2124215-2014-15976
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/25/2007
• Device Model Number: T180
• Other Device ID Number: VITALITY DR HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2006
• 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: 0184; T180
• Patient Age: 33 YR