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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 No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2018
Event Type  Injury  
Manufacturer Narrative

At this time, the product has not been returned. If the product is returned, analysis will be performed and this report would be updated at that time.

 
Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) exhibited noise and oversensing on the right ventricular (rv) lead that resulted in an inappropriate shock being delivered. Surgical intervention was performed to replace the rv lead and the icd. This icd was explanted. 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 Key7983688
MDR Text Key124299415
Report Number2124215-2018-18470
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
Report Date 08/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/14/2009
Device MODEL NumberT177
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 Received08/22/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/18/2008
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: 10/19/2018 Patient Sequence Number: 1
Treatment
0295; 1850; 4137; D150; MISMATCH; SP01; T177
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