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

Model Number T167

Device Problems Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2007

Event Type  Injury  

Manufacturer Narrative

Upon receipt, visual inspection noted no device anomalies.All of the seal plugs were intact.The device was successfully interrogated and was found with a battery status indicator of end-of-life (eol) with a monitoring voltage of 2.45 volts.Engineering calculations determined that this device did meet expected longevity.The device was put through and passed manual therapy verification testing.Pacing, sensing, and shocking functions were verified per manual bench top testing.The recorded pacing and shock impedance measurements were within normal limit.It was concluded that this device performed normally throughout laboratory testing.An initial report was previously submitted to fda on (b)(4) 2007; however due to emdr submission issue related to the supplemental report, this is being filed again as an initial report.

Event Description

Boston scientific received information in (b)(6) 2007 that this local sales representative contacted technical services to report that this implantable cardioverter defibrillator (icd) device and implantable transvenous right ventricular lead was exhibiting pacing inhibition.The patient is pacemaker dependent.A fax was received by technical services and review of the telemetry strips identified apparent atrial pace with no ventricular pace/sense beats.Technical services discussed possible oversensing-crosstalk versus isoelectric pvc.Review of additional telemetry strips identifies intracardiac ventricular noise associated with pauses in ventricular paced events.Some ventricular escape beats were identified.Noninvasive diagnostic lead tests have been normal.Pacing thresholds testing was normal during patient arm isometrics.Technical services discussed possible set screw issue versus air behind the set screw.The caller indicated that the patient will be monitored for now.Boston scientific received information that this patient was presented back to the electrophysiology (ep) laboratory on (b)(6) 2015.The device was electively explanted due to normal battery depletion.

• 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: 5491158
• MDR Text Key: 40016936
• Report Number: 2124215-2016-03999
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/16/2007

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2008
• Device Model Number: T167
• Other Device ID Number: VITALITY 2 DR EL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/16/2007
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2007
• 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: 0137
• Patient Outcome(s): Life Threatening
• Patient Age: 88 YR