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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 Problem Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Date 12/14/2016
Event Type  Malfunction  
Manufacturer Narrative

The device was returned and is undergoing laboratory analysis. This report will be updated when analysis is complete.

 
Event Description

Boston scientific received information that the patient implanted with this implantable cardioverter defibrillator (icd) was lost to follow-up. It was reported the last device check was likely in 2011. After the patient died, the physicians tried to interrogate the device but a red warning screen was displayed that stated no brady and tachy therapies were available. The device was explanted and will be returned for laboratory analysis to confirm the device functioned normally. It was requested to know if the device had reached end of life (eol) and if so, on what date. The cause of death was not provided. There were no allegations that the device caused or contributed to the patient¿s death.

 
Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed. A visual inspection of the device header and case noted no anomalies. A review of the device memory found the device was in factory fallback mode. The device had reached elective replacement indicator (eri) battery status on (b)(6) 2015 and had reached end of life (eol) battery status on (b)(6) 2016. A watchdog timer reset had occurred, indicating a function being executed was exceeding its expected execution time. The power on reset factory fallback condition occurred due to high lead impedances; and occurred after the patient¿s death. Evidence indicates the device was functioning normally prior to the patient¿s death.

 
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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
sonali vasekar
4100 hamline ave. n
st. paul, MN 
6515824786
MDR Report Key6290484
MDR Text Key66196011
Report Number2124215-2017-01676
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 02/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/12/2008
Device MODEL NumberT175
OTHER Device ID NumberVITALITY 2 VR
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/03/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received02/10/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/16/2007
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: 01/31/2017 Patient Sequence Number: 1
Treatment
(B)(4); (B)(4)
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