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

Model Number T180

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

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

Event Date 04/09/2010

Event Type  Injury  

Manufacturer Narrative

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 consecutive charge times greater than the extended mid-life eri charge time limit.The observed rate of battery usage was compared to the expected rate of battery usage; the results indicated that the monitoring voltage was normal.Although the battery itself had not depleted prematurely, eri was triggered earlier than expected by extended charge times due to a higher-than-typical buildup of internal battery impedance.

Event Description

Boston scientific received information that a clinician contacted boston scientific technical services (ts) and reported that this device emitted tones and the charge time was measured to be 20 seconds at the last follow-up appointment.Ts discussed with the clinician that it is possible that the device may be emitting tones because the device reached a battery status of elective replacement indicator (eri).The device was explanted.Additional information from the field representative indicates that there was no allegation at time of explant and the monitoring voltage was as expected for a device at eri.There were no adverse patient effects.

• 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 ; 6515824786
• MDR Report Key: 5380513
• MDR Text Key: 36421928
• Report Number: 2124215-2015-14376
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/23/2006
• Device Model Number: T180
• Other Device ID Number: VITALITY DR HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2005
• 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: T180
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR