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

Model Number T180

Device Problems Pacing Problem (1439); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2014

Event Type  Injury  

Event Description

Boston scientific received information that the patient with this device system was presented to the hospital with a heart rate in the 20 bpm to 30 bpm.It was noted that transthoracic pacing was applied at a rate of 50 bpm.The local area sales representative reported that the patient was evaluated and found to have a battery voltage of 2.10v with no pacing and the device reverted to storage mode.A revision procedure was performed and the device was explanted and replaced.

Event Description

Additional information was received that the device was returned for reliability analysis.

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.

Manufacturer Narrative

(b)(4).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 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 3905370
• MDR Text Key: 4492848
• Report Number: 2124215-2014-11316
• 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,Followup
• Report Date: 07/15/2014

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: 08/22/2008
• Device Model Number: T180
• Other Device ID Number: VITALITY DR HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 07/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2007
• 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: T180; 0185; 4470
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 35 YR