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

Model Number T177

Device Problems Device Alarm System (1012); Premature Discharge of Battery (1057); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2013

Event Type  Injury  

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) was beeping and was at elective replacement indicator (eri) due to extended charge time.It was alleged that the device battery depleted unexpectedly.The icd was explanted and replaced.The icd was no longer in service.No additional adverse patient effects were reported.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

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: sharon zurn ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 3600162
• MDR Text Key: 21053350
• Report Number: 2124215-2013-21064
• 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
• Report Date: 12/04/2013

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: 07/16/2008
• Device Model Number: T177
• Other Device ID Number: VITALITY 2 VR EL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/04/2013
• Initial Date FDA Received: 01/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2007
• 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: T177; 0148
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention