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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 Problem No Patient Involvement (2645)
Event Date 07/19/2017
Event Type  malfunction  
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed. Interrogation of the device confirmed it was operating in safety core and that both brady and tachy therapy remained available. Review of device memory identified a fault. The fault resulted in software resets performed in an attempt to correct an identified memory inconsistency. The corrupted memory was corrected in the laboratory and the device reverted to normal operation. The cause of the memory inconsistency was not able to be determined through laboratory testing.
 
Manufacturer Narrative
The product has been received for analysis. This report will be updated upon completion of analysis.
 
Event Description
Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) was observed to be in safety mode while still in the box prior to any attempt to implant. Boston scientific technical services (ts) recommended returning the device. There was no patient involved and the device had not been used.
 
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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 Key6918076
MDR Text Key100091106
Report Number2124215-2017-14283
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 08/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/27/2018
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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