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

Model Number T175

Device Problems Defibrillation/Stimulation Problem (1573); Device Displays Incorrect Message (2591)

Patient Problem Ventricular Tachycardia (2132)

Event Date 06/06/2015

Event Type  Injury  

Event Description

Additional information was received indicating the patient underwent a revision procedure wherein this device eas explanted and replaced.No additional adverse patient effects were reported.

Event Description

Boston scientific received information that this device exhibited a code indicating a charge timeout during attempted therapy resulting in declaration of end of life (eol).Device replacement was recommended however no timeline for replacement has been established.No adverse patient effects were reported.This device remains in service at this time.

Manufacturer Narrative

(b)(4).The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Manufacturer Narrative

(b)(4).This device is expected for return and analysis following explant.This report will be updated should additional information be received.

Manufacturer Narrative

(b)(4).Despite efforts, no further information regarding the return status of this device could be obtained.This report will be updated should the device be returned for analysis.

Event Description

• 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: 4884881
• MDR Text Key: 6052158
• Report Number: 2124215-2015-08084
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/03/2010
• 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: 06/17/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2009
• 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: T175
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR