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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); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Patient Problem Ventricular Tachycardia (2132)
Event Date 06/19/2017
Event Type  Injury  
Manufacturer Narrative

The product has been received for analysis. This report will be updated upon completion of analysis.

 
Event Description

Boston scientific received information that the patient was hospitalized after receiving appropriate therapy for ventricular tachycardia (vt). Upon interrogation it was found that there was oversensing of noise on the right ventricular (rv) channel. It was believed that the patient's left ventricular assist device (lvad) contributed to the noise. Boston scientific technical services (ts) was consulted and discussed programming options. At that time the physician opted to continue to monitor the patient. Ten days later it was noted that the rv lead threshold measurement had increased and the rv amplitude fluctuated from 2. 0 to 4. 5 milliseconds which resulted in further oversensing of the lvad and multiple inappropriate shocks. It was thought that the lvad damaged the rv lead which contributed to this issue. The pace sense portion of the rv lead was surgically abandoned and replaced. The shocking portion of the rv lead remains in service. The new pace sense lead was placed near the outflow tract. The implantable cardioverter defibrillator (icd) was also explanted and replaced during the procedure. No further oversensing was observed with the new icd and pace sense rv lead. 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, right ventricular pacing, and sensing functions were tested. The device operated appropriately with no interruptions in therapy output at the returned programmed settings.

 
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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 Key6717904
MDR Text Key80174475
Report Number2124215-2017-12347
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
Type of Report Initial,Followup
Report Date 07/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/17/2008
Device MODEL NumberT177
OTHER Device ID NumberVITALITY 2 VR EL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/06/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received07/25/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/22/2007
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: 07/17/2017 Patient Sequence Number: 1
Treatment
0185; T177
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