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

Model Number T177

Device Problems Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917); Impedance Problem (2950); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

Boston scientific received information that during a routine follow-up, oversensed noise was noted on the right ventricular channel which was stored as high rate ventricular events.This led to the patient receiving four bursts of anti-tachycardia pacing and a shock.A slight fluctuation in pacing impedances were also noted, but no measurements were out of range.The patient's device was later explanted and replaced without any further allegations made against it.No adverse patient effects were reported.

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, a review of device memory revealed that the device declared elective replacement indicator (eri) after experiencing two charge times greater than the charge time limit.End of life (eol) was declared following a single charge time greater than 30 seconds.The observed rate of battery usage was compared to the expected rate of battery usage and the results indicated the monitoring voltage was normal based on therapy use and programmed settings.It was concluded that this device did not experience premature battery depletion.Rather, the eri to eol time period was shortened due to a higher-than-typical buildup of internal battery impedance.The device was capable of detecting and treating arrhythmias, as the battery itself had sufficient capacity remaining to provide therapy if needed.Analysis was not able to confirm the previous allegations made against this device in the field.

• 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: 4916679
• MDR Text Key: 20442650
• Report Number: 2124215-2015-09200
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P960040
• 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: 06/17/2015

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: 07/16/2008
• Device Model Number: T177
• Other Device ID Number: VITALITY 2 VR EL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2007
• 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: T177; 0165
• Patient Age: 84 YR