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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2014

Event Type  Injury  

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) is suspected to have premature battery depletion (pbd).Last routine follow up in january of this year showed device longevity at middle of life (mol) status.Approximately one month later, the device exhibited tones as the device was at elective replacement indicator (eri).Normal measurements were observed on the electrodes.Device was then explanted and was sent for analysis.This icd is out of service.No additional adverse patient effects were reported.

Event Description

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Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.During initial investigation, it was reported that the device did not have an elective replacement indicator (eri) timestamp and that end of life (eol) was declared while implanted.Memory analysis found that eol was declared in result of a long charge time.The cause of the long charge time was not determined.Further detailed analysis found no functional irregularities in device operation.All therapy, sensing, and pacing was available at the time of explant.Laboratory analysis confirmed the reported clinical observation.

• 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: 3790197
• MDR Text Key: 4440218
• Report Number: 2124215-2014-06048
• 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: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2009
• 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: 03/20/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2008
• 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; 0175
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention