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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 Problems Pacing Problem (1439); Under-Sensing (1661)
Patient Problems Syncope (1610); Atrial Fibrillation (1729)
Event Date 04/18/2016
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. Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
The cardiac resynchronization therapy pacemaker (crt-p) was returned approximately two and a half years later from a funeral home. No further allegations were made agains the product.
 
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
Boston scientific received information that the patient experienced syncope and came to the emergency room. Upon interrogation it was noted that the cardiac resynchronization therapy pacemaker (crt-p) was pacing at a high rate. Boston scientific technical services (ts) was consulted and reviewed strips. However, it was not fully able to be determined if it was high rate pacing or true ventricular tachycardia (vt). It was noted that the patient was in atrial fibrillation (af) and an ablation procedure had occurred at the time of implant. Further review found that there was functional undersensing due to programming the sensitivity at a fixed value, which was causing over pacing. An x-ray was taken which did not show any significant findings. Thus the physician performed another av node ablation procedure. At this time the crt-p remains in service and 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 Key5787844
MDR Text Key130689398
Report Number2124215-2016-08792
Device Sequence Number1
Product Code NKE
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 Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/05/2017
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received11/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2015
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: 07/12/2016 Patient Sequence Number: 1
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