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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 Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2017
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 during the implant procedure, difficulty was experienced inserting the right atrial (ra) lead into the cardiac resynchronization therapy pacemaker (crt-p) header. The lead was successfully inserted into the device header and the implant procedure was completed without further complication. 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 Key7197128
MDR Text Key97789344
Report Number2124215-2017-22795
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
Type of Report Initial
Report Date 12/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/06/2019
Device Model NumberU128
Other Device ID NumberVALITUDE 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 Received12/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2017
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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