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

Model Number T165

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pregnancy (3193)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this device declared elective replacement indicator (eri) with a charge time of 26 seconds and a battery voltage of 2.51 volts.The previous charge time was noted to be 0.0 seconds.The caller inquired if the 0.0 seconds charge time was due to the extended capacitor reform time.A boston scientific technical services consultant discussed the possibility that the device was charged to full capacity and then a charge was aborted shortly before the scheduled capacitor reform occurred.The caller stated that the patient is pregnant and since the most recent charge time was extended, the device will most likely be explanted.A replacement procedure was performed and a competitive replacement device was implanted.No additional adverse patient effects were reported.

• 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: 6023225
• MDR Text Key: 57184736
• Report Number: 2124215-2016-16174
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2010
• Device Model Number: T165
• Other Device ID Number: VITALITY 2 DR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2009
• 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: 0184; 1688TC; 4472; T165
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 32 YR