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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 Failure to Capture (1081); High impedance (1291)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/24/2018
Event Type  Injury  
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 this cardiac resynchronization therapy pacemaker (crt-p) exhibited out of range pace impedances on the left ventricular (lv) lead. The values were greater than 2000 ohms. In addition, loss of capture on the lv was observed at maximum outputs. A revision procedure was scheduled. The lv lead was then explanted and replaced. This crt-p remains in service. The lead was not tested via pacing system analyzer during the revision and no damage was observed on the lead. 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 Key7496223
MDR Text Key107652787
Report Number2124215-2018-08261
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/18/2016
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 Received03/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2014
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: 05/08/2018 Patient Sequence Number: 1
Treatment
1346T; 1688TC; 4543; 5820; S603; V173
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