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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 No Consequences Or Impact To Patient (2199)
Event Date 12/22/2017
Event Type  malfunction  
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 with this device presented for follow-up when noise and oversensing were observed which reportedly did contribute to pacing inhibition of around two seconds. No resulting adverse patient effects and technical services (ts) was contacted. Ts agreed with the programming changes and keeping the minute ventilation feature off. No further changes 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
tim degroot
4100 hamline ave. n
st. paul, MN 
6515826168
MDR Report Key7354323
MDR Text Key102967230
Report Number2124215-2018-03511
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 02/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/19/2018
Device Model NumberU228
Other Device ID NumberVISIONIST X4
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 Received02/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2016
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: 03/20/2018 Patient Sequence Number: 1
Treatment
4457; 4674; 4677; U228
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