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

Model Number T180

Device Problems Device Alarm System (1012); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2013

Event Type  Injury  

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead were exhibited high voltage impedance and was beeping.A boston scientific technical services (ts) gave estimated report of 2.5 volts at 12.5 second for this device, the same reports that was given last several months.Additional information obtained from the field representative that the cause of high voltage was not determined.This icd was explanted for normal battery depletion and was replaced while the lead remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing and sensing functions were tested.The device operated appropriately, according to its performance specifications, with no interruptions in therapy output or programmer communication at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.

• Brand Name: VITALITY
• 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: sharon zurn ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 3610144
• MDR Text Key: 18362512
• Report Number: 2124215-2014-02479
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/17/2013

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: 12/07/2006
• Device Model Number: T180
• Other Device ID Number: VITALITY DR HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/17/2013
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2005
• 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: 0157; 1853; 4469; T180; 1861
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 30 YR