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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 Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2014
Event Type  Malfunction  
Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory a thorough analysis completed and reviewed. Analysis was able to determine that the device met the expected longevity, but had a shortened eri to eol depletion.

 
Event Description

Boston scientific received information that this defibrillator produced inappropriate shocks due to noise. The device was then programmed off. The device was later explanted. No additional adverse patient effects were reported.

 
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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 Key7190517
MDR Text Key97645591
Report Number2124215-2017-19544
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 10/12/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/19/2007
Device MODEL NumberT175
OTHER Device ID NumberVITALITY 2 VR
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/21/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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