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U.S. Department of Health and Human Services

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

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GUIDANT CRM CLONMEL IRELAND VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
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.

 
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Brand NameVITALITY 2
Type of DeviceIMPLANTABLE 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 Key7183565
MDR Text Key97011563
Report Number2124215-2017-23652
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/06/2008
Device MODEL NumberT175
OTHER Device ID NumberVITALITY 2 VR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/10/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/11/2018 Patient Sequence Number: 1
Treatment
0147; 1850; T175
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