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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 Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2017
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) and right ventricular (rv) lead exhibited noise and oversensing that led to pacing inhibition and asystole. Fluoroscopy did not find any lead anomalies. A system revision took place. The rv lead was tested with a pacing system analyzer (psa), and no abnormalities were observed. During the revision procedure, the lead header connection was assessed. Noise was able to be reproduced when moving the device inside the pocket and when tugging on the lead to see if the lead connection was secure. This rv lead was capped and noise persisted with this device and a new rv lead. The physician elected to explant and replace the device due to a possible header issue. 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 
6515824786
MDR Report Key6476192
MDR Text Key72242095
Report Number2124215-2017-01842
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
Reporter Occupation
Type of Report Initial
Report Date 01/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/16/2015
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 Received01/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2013
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: 04/10/2017 Patient Sequence Number: 1
Treatment
1296; 1688TC; 4472; 4473; MISMATCH; S606; V173
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