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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 T177
Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/11/2017
Event Type  Injury  
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 this implantable cardioverter defibrillator (icd) exhibited noise on the right ventricular (rv) channel. The noise was oversensed which resulted in pacing inhibition, but no asystole. The rv lead and icd were explanted and replaced. The cause of the observations was not determined. No additional adverse patient effects were reported.

 
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. Pin gauge testing, designed to verify proper port dimensions, was completed. Each port measured as expected. The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested. Impedance testing was completed and all measurements were within normal limits. The device operated appropriately with no interruptions in therapy output at the returned programmed settings. A series of electrical tests was also performed, and again, normal device function was observed. Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

 
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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 Key6943845
MDR Text Key89254510
Report Number2124215-2017-16708
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP960040/S039
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 10/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/15/2008
Device MODEL NumberT177
OTHER Device ID NumberVITALITY 2 VR EL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/17/2007
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: 10/12/2017 Patient Sequence Number: 1
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