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U.S. Department of Health and Human Services

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

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GUIDANT CRM CLONMEL IRELAND VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number T125
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 12/12/2012
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 medical records received a phone call from the patient's brother reporting that the patient passed away in (b)(6) 2012. The caller stated the patient had a heart attack and the device did not function. There have been no reported allegations to this date by any medical professionals. The device was not returned to boston scientific.

 
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Brand NameVITALITY
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 Key5926983
MDR Text Key53893689
Report Number2124215-2016-14011
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 OTHER
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 08/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/25/2006
Device MODEL NumberT125
OTHER Device ID NumberVITALITY DS DR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/26/2005
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: 09/02/2016 Patient Sequence Number: 1
Treatment
0184; 4469; T125
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