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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE IMPLANTABLE PULSE GENERATOR

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GUIDANT CRM CLONMEL IRELAND ACCOLADE IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number U128
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Cardiac Arrest (1762); Insufficiency, Valvular (1926); Ventricular Fibrillation (2130); Complete Heart Block (2627); Patient Problem/Medical Problem (2688)
Event Date 04/29/2016
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 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. Laboratory 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 this patient with a cardiac resynchronization therapy pacemaker (crt-p) had a ventricular fibrillation (vf) arrest without any clear cause. The patient has a recent history of a coronary artery bypass graft procedure, mitral valve and tricuspid valve repair, and complete heart block. The patient was then referred for an upgrade to a cardiac resynchronization therapy defibrillator (crt-d). On the day of the replacement procedure, the field representative noted that the displayed date of the last capacitor reform was not as expected. Boston scientific technical services (ts) was contacted for assistance and troubleshooting revealed that the programmer date and time was not updated, which was likely the cause of the capacitor reform date discrepancy. This crt-p was explanted and replaced by a crt-d. No additional adverse patient effects were reported.
 
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Brand NameACCOLADE
Type of DeviceIMPLANTABLE PULSE GENERATOR
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
sonali vasekar
4100 hamline ave. n
st. paul, MN 
6515824786
MDR Report Key5789252
MDR Text Key49368531
Report Number2124215-2016-09574
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 04/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/08/2018
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received04/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2016
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: 07/13/2016 Patient Sequence Number: 1
Treatment
G148
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