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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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2018
Event Type  Injury  
Manufacturer Narrative
This device has been returned 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 explanted and replaced, and a pocket revision was performed for unknown reasons. Additional information has been requested, but was unavailable. No additional adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed. A visual inspection of the device header and case noted no anomalies. The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested. Impedance testing was completed and all measurements were within normal limits. The device operated appropriately with no interruptions in therapy output at the returned programmed settings. A series of electrical tests was also performed, and again, normal device function was observed.
 
Event Description
Additional information was received which noted that there were no allegations against the device. A new device was implanted for different device functionality for the patient. 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
tim degroot
4100 hamline ave. n
st. paul, MN 
6515826168
MDR Report Key7362161
MDR Text Key103189134
Report Number2124215-2018-04297
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/10/2016
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2014
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: 03/22/2018 Patient Sequence Number: 1
Treatment
4470; 4549; 4671; 4674; 7121; MISMATCH; N119; U128
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