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

Model Number T180

Device Problems Device Alarm System (1012); High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2013

Event Type  malfunction  

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead displayed a gradual increase in shock lead impedance (sli) measurements from 39 ohms to 102 ohms.Also, extended charge times were observed however remain within the extended charge time limit.The source of this clinical observations was not determined.A 1.1 joule synchronized shock and full energy shock was delivered which resulted in 87 ohms and 97 ohms, respectively.Two defibrillation threshold (dfts) tests were also performed with shocking impedance measurements of 98 ohms and 89 ohms.The patient will continue to be monitored for any out-of-range (oor) shocking impedance values.Additional information was obtained indicating that the patient heard the device was beeping.The field representative said that the device had not reached elective replacement indicator (eri) but the sli measurements were now up around 124 ohms.All other measurements were fine.They verified that the cause of beeping was an oor message in the daily test.Boston scientific technical services (ts) discussed performing commanded shocks to test the device¿s ability to deliver a shock successfully.The cause was not conclusively determined and no actions taken at this time.The system 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
• 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: 3916742
• MDR Text Key: 4489101
• Report Number: 2124215-2014-12418
• 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: 05/09/2014

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: 10/11/2007
• Device Model Number: T180
• Other Device ID Number: VITALITY DR HE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2006
• 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: T167; T180; 4470; 0184
• Patient Age: 44 YR