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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 Known Impact Or Consequence To Patient (2692)
Event Date 10/12/2016
Event Type  malfunction  
Manufacturer Narrative
The local area sales representative was contacted for additional information. At this time, no further information is available. Should additional information become available this report will be updated.
 
Event Description
Boston scientific received information that the patient contacted a boston scientific company representative to report that the remote home monitoring communicator displayed a red blinking light indicating the presence of a potential product performance issue related to this cardiac resynchronization therapy pacemaker (crt-p). The patient was referred to their clinic/physician. No adverse patient effects were reported. This product remains implanted and in service.
 
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 was received from a health care professional (hcp) that the patient was unenrolled from the home monitoring system and the patient planned to follow up with another physician on an unknown date in the future. No additional information was available.
 
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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 Key6193653
MDR Text Key62966616
Report Number2124215-2016-17294
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 10/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2018
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 Received10/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2016
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: 12/21/2016 Patient Sequence Number: 1
Treatment
4469; 4674; U128
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