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

Model Number T165

Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

According to the field, the device will not be returned for analysis.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this device was oversensing noise on the right ventricular (rv) pace/sense channel which led to pacing inhibition with greater than four seconds of asystole.Surgical intervention was performed and the device was explanted.The patient did not experience any syncope and there were no adverse patient effects reported.

• 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 ; 6515824786
• MDR Report Key: 5372950
• MDR Text Key: 36204645
• Report Number: 2124215-2015-15850
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S039
• 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: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2010
• 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
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2009
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR