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U.S. Department of Health and Human Services

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

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GUIDANT CRM CLONMEL IRELAND INGENIO IMPLANTABLE CHF GENERATOR Back to Search Results
Model Number V173
Device Problem Failure to Capture (1081)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 05/10/2018
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 left ventricular (lv) threshold testing on this pacemaker, pressing the end test button on the programmer/recorder/monitor (prm) did not stop the test. As a result, at least three seconds of lv loss of capture occurred, resulting in a near-syncopal episode for the patient. This device remains in service.
 
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Brand NameINGENIO
Type of DeviceIMPLANTABLE CHF 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 Key7630905
MDR Text Key112088152
Report Number2124215-2018-11120
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/11/2015
Device Model NumberV173
Other Device ID NumberINVIVE
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 Received05/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2013
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: 06/22/2018 Patient Sequence Number: 1
Treatment
1888TC; MISMATCH; V173
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