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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2016
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested. This report will be updated should further information be received.
 
Event Description
Boston scientific received information that the remote monitoring communicator displayed a red call doctor icon, indicative of a compromised critical therapy condition that was detected with this device, which was unable to be transmitted to the remote monitoring server. This device remains in service. No adverse patient effects were reported.
 
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
Additional information from the device clinic nurse indicates that there have been no out-of-range measurements detected by the remote monitoring system and there are no concerns about the device function or the patient's condition. This device remains in service. No 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 Key6024122
MDR Text Key57323630
Report Number2124215-2016-16486
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 consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 11/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/04/2016
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received11/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2015
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: 10/12/2016 Patient Sequence Number: 1
Treatment
4470; 4471; MISMATCH; S606; U128
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