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

Model Number T165

Device Problems Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Cardiac Arrest (1762)

Event Date 06/23/2015

Event Type  malfunction  

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) oversensed noise on the right atrial (ra) lead and right ventricular (rv) lead channels resulting in pacing inhibition greater than 2 seconds in duration.Boston scientific technical services (ts) noted that the noise appears myopotential in nature and suspects lead insulation damage possibly from lead-on-lead contact.The device was reprogrammed and remains in service.No adverse patient effects were reported.

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: 4913720
• MDR Text Key: 6051522
• Report Number: 2124215-2015-09117
• 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: Physician
• Type of Report: Initial
• Report Date: 06/23/2015

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: 11/05/2010
• Device Model Number: T165
• Other Device ID Number: VITALITY 2 DR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2009
• 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: 4096; 0185; T165