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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); Pacing Problem (1439); Ambient Noise Problem (2877)
Patient Problems Syncope (1610); Dizziness (2194)
Event Date 05/22/2018
Event Type  Injury  
Manufacturer Narrative
The device remains in service at this time. If additional information is received, this report will be updated.
 
Event Description
Boston scientific received information that the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room with dizzy spells. The device and a non-boston scientific right ventricular (rv) lead exhibited noise, oversensing, pacing inhibition of approximately two seconds, and impedance measurements of greater than 2000 ohms. It was questioned if the noise could have been due to minute ventilation (mv) oversensing, although it was noted that the noise did not look like mv signals. This feature was programmed off. Patient isometrics were performed which did not reproduce any noise. The patient had also experienced a syncopal event. There were no events stored in the device at the time of the syncope; however, it was noted that the events may have been overwritten. Programming options were discussed at that time. A lead fracture was suspected. A surgical revision was performed and the non-boston scientific rv lead was surgically abandoned and replaced. This device remains in service with the new 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 Key7755742
MDR Text Key116204359
Report Number2124215-2018-15017
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2016
Device Model NumberV173
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 Received05/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2014
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: 08/07/2018 Patient Sequence Number: 1
Treatment
4135; 4549; 5076; V173
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