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

Model Number T175

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

Boston scientific received information that information that this implantable cardioverter defibrillator (icd) delivered anti-tachycardia pacing (atp) which accelerated the patient's rhythm into the ventricular tachycardia (vt) zone where shock therapy was delivered.Therapy was exhausted.It was unclear whether the patient's rhythm was supraventricular tachycardia (svt) or a true ventricular tachycardia (vt).Boston scientific technical services discussed potential programming changes.There were no adverse patient effects.The device remains in service.

Manufacturer Narrative

(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• 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 55112 ; 6515824786
• MDR Report Key: 4452957
• MDR Text Key: 21560966
• Report Number: 2124215-2015-01150
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/24/2014

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: 04/01/2009
• Device Model Number: T175
• Other Device ID Number: VITALITY 2 VR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2008
• 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: 0185; T175
• Patient Age: 67 YR