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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 Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/22/2018
Event Type  Injury  
Manufacturer Narrative

No further information has been provided to date. This report will be updated should additional information become available.

 
Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) delivered an inappropriate shock due to noise and oversensing on the right ventricular (rv) lead. Device review found numerous stored episodes showing noise on the rv pace/sense channel; the shock channel of the lead was free of artifact. All lead measurements were within normal limits and stable. Provocation testing was performed and noise was reproduced when the patient engaged their pectoral muscles; insulation damage was the suspected cause of the observed noise. Device therapy was programmed off and the patient admitted to the hospital pending a revision procedure. A procedure was later performed wherein the patient was implanted with a s-icd system; the chronic icd and lead were deactivated pending removal at a later time. No 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 Key7362395
MDR Text Key103196741
Report Number2124215-2018-05121
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeIT
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
Report Date 02/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/28/2011
Device MODEL NumberT175
OTHER Device ID NumberVITALITY 2 VR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received02/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/25/2010
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: 03/22/2018 Patient Sequence Number: 1
Treatment
0145; 0148; 1790; T175
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