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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 T165
Device Problems Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2013
Event Type  malfunction  
Event Description
Boston scientific received information that this implantable cardioverter defibrillator (icd) oversensed right atrial (ra) activity on the right ventricular (rv) lead resulting in inappropriate anti-tachycardia pacing (atp) and shock therapy.Therapy was reported to have been exhausted.No adverse patient effects.Device reprogrammed to mitigate recurrence.Device remains in service.
 
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
New information received indicates that this device has since been explanted for normal battery depletion.The device was given to the patient and will not be returned for analysis.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
VITALITY 2
Type of Device
IMPLANTABLE 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
sharon zurn
4100 hamline ave. n
st. paul, MN 55112
6515824786
MDR Report Key3570765
MDR Text Key4074905
Report Number2124215-2013-20532
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
PMA/PMN Number
P960040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/01/2009
Device Model NumberT165
Other Device ID NumberVITALITY 2 DR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 08/11/2014
Initial Date FDA Received01/13/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
1861; T165; 0147; MISMATCH
Patient Age82 YR
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