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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INGENIO IMPLANTABLE PULSE GENERATOR

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GUIDANT CRM CLONMEL IRELAND INGENIO IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number V273
Device Problems Pacing Problem (1439); Device Operates Differently Than Expected (2913)
Patient Problems Syncope (1610); Atrial Tachycardia (1731)
Event Date 10/12/2017
Event Type  Injury  
Manufacturer Narrative
A boston scientific technical services consultant documented and discussed the clinical observations with the caller. Efforts to obtain additional product issue details were unsuccessful. 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 this patient experienced a syncopal event. A review of the presenting data showed the device was operating as programmed. There were some pacemaker mediated tachycardia (pmt) stored episodes from the past seventy-two hours which appear to be due to atrial tachycardia (at) causing the device to pace at the maximum tracking rate (mtr). No adverse patient effects were reported.
 
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Brand NameINGENIO
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 Key7190538
MDR Text Key97283368
Report Number2124215-2017-20383
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
Type of Report Initial
Report Date 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/09/2016
Device Model NumberV273
Other Device ID NumberINTUA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2014
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: 01/15/2018 Patient Sequence Number: 1
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