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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 T167
Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2018
Event Type  Injury  
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. 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.

 
Event Description

Boston scientific received information that the non-boston scientific right ventricular (rv) lead connected to this implantable cardioverter defibrillator (icd) experienced many episodes of noise with oversensing. The patient was shocked inappropriately due to oversensing of the rv lead noise. It was reported that there was not pacing inhibition and that the patient had an underlying rhythm of 71 beats per minute. Sensing, impedance, and thresholds all appeared to be normal. Rv lead fracture was suspected, but was not able to be confirmed via x-ray. The non-boston scientific rv lead was surgically abandoned and the icd was explanted and replaced. 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 Key7979979
MDR Text Key124168808
Report Number2124215-2018-18427
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
Report Date 07/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/21/2009
Device MODEL NumberT167
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received07/31/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/23/2008
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: 10/18/2018 Patient Sequence Number: 1
Treatment
6942; MISMATCH; T167
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