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

Model Number T175

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2016

Event Type  Injury  

Manufacturer Narrative

Following return and completion of laboratory analysis, this event will be further updated.

Event Description

Boston scientific received information that this device was explanted following the eri indicator during a routine follow-up.No resulting adverse patient effects and the explant device is intended to be returned for a longevity assessment.

Manufacturer Narrative

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Event Description

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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.

• 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: 6026194
• MDR Text Key: 57302642
• Report Number: 2124215-2016-16618
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2016

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: 09/11/2014
• Device Model Number: T175
• Other Device ID Number: VITALITY 2 VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/21/2016; 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• 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: F141; T175
• Patient Outcome(s): Hospitalization; Required Intervention