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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 Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2017
Event Type  Injury  
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 tool marks on the case and bloody fluid contamination in the lead barrels. Further inspection noted that there was a hole in the left ventricular (lv) and right ventricular (rv) seal plugs. Pin gauge testing, designed to verify proper port dimensions, was completed. Each port measured as expected. Impedance testing was completed and all measurements were within normal limits. A series of electrical tests was also performed, and again, normal device function was observed. Laboratory analysis confirmed damage to the seal plugs, however, did not confirm the noise or high out of range pacing impedance measurements as this was not duplicated during laboratory testing.
 
Event Description
Additional information was received that lead to device header connections were verified to be appropriate. The seal plug appeared to be leaking as liquid was observed behind the seal plugs.
 
Manufacturer Narrative
At this time, the product has not been returned. If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event Description
Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) and right ventricular (rv) lead exhibited noise, oversensing and high out of range pacing impedance measurements greater than 2,000 ohms. A device header seal plug problem was suspected. An invasive procedure was performed. The device was explanted and replaced and the lead was surgically abandoned and replaced. No additional adverse patient effects were reported.
 
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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 Key6931637
MDR Text Key100324305
Report Number2124215-2017-14235
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,Followup
Report Date 08/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/19/2016
Device Model NumberV173
Other Device ID NumberINVIVE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2014
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: 10/09/2017 Patient Sequence Number: 1
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