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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 U228
Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)
Patient Problem Fatigue (1849)
Event Date 08/31/2018
Event Type  malfunction  
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 pacemaker and competitor right ventricular (rv) lead exhibited instances of noise and oversensing. Upon review of stored episodes it was noted that there were some instances of pacing inhibition lasting up to approximately 3 seconds. The patient was reported to be right atrial pacing dependent and experienced some symptoms of fatigue as a suspected result of periodic av dysynchrony. Suggestions for system evaluation were provided. This system remains in service.
 
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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
tim degroot
4100 hamline ave. n
st. paul, MN 
6515826168
MDR Report Key7984071
MDR Text Key124341190
Report Number2124215-2018-18436
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/31/2018
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? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/22/2020
Device Model NumberU228
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 Received08/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2018
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
4671; 5024; 5524; K283; SEDRL1; U228
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