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

Patient Problem Syncope (1610)

Event Date 10/09/2014

Event Type  Injury  

Event Description

Boston scientific received information that the patient implanted with this implantable cardioverter defibrillator (icd) presented to the hospital following a syncopal episode and fall.The patient had a history of atrial fibrillation (af) with rapid ventricular response (rvr).Review of stored device memory revealed a potential episode of af with rvr where inappropriate anti-tachycardia pacing (atp) and shock therapy was delivered.Boston scientific technical services (ts) reviewed the episode and discussed therapy was delivered appropriately based on programming and detection enhancements.The cause of syncope was unable to be determined.No additional adverse patient effects were reported.The device was explanted and replaced with another manufacturer's device.

Manufacturer Narrative

(b)(4).The product has been received for analysis.This report will be updated upon completion of analysis.

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, right ventricular pacing, and sensing functions were tested.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• 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: 4396699
• MDR Text Key: 5308825
• Report Number: 2124215-2014-19434
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2014

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: 04/06/2008
• Device Model Number: T175
• Other Device ID Number: VITALITY 2 VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 01/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2007
• 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: 0184; T175
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR