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

Model Number T175

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 12/05/2017

Event Type  Death  

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 the patient implanted with this implantable cardioverter defibrillator (icd) and right ventricular (rv) defibrillation lead was admitted to the hospital due to infection.Interrogation of the device with a programmer noted the device was in storage mode and had reached end of life (eol) status approximately two years ago.The patient indicated that they had been lost to follow up for approximately two years and was aware of the eol status.No further information was provided to the local field representative.Available information indicates that this product remains implanted and in service.No additional adverse patient effects were reported.

Event Description

Additional information was received that an echocardiogram was performed and noted vegetation on the lead.An invasive procedure was performed.The device and lead were explanted and antibiotics were administered.Subsequently, the patient expired shortly after the explant procedure.A tear of the superior vena cava was suspected.

• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7183565
• MDR Text Key: 97011563
• Report Number: 2124215-2017-23652
• 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: 01/02/2018

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: 07/06/2008
• Device Model Number: T175
• Other Device ID Number: VITALITY 2 VR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2007
• 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: 0147; 1850; T175
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR