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U.S. Department of Health and Human Services

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

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GUIDANT CRM CLONMEL IRELAND INGENIO IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number V273
Device Problems Failure to Capture (1081); Under-Sensing (1661); Ambient Noise Problem (2877)
Patient Problems Weakness (2145); Dizziness (2194); No Known Impact Or Consequence To Patient (2692)
Event Date 10/06/2016
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 functional undersensing, noise and loss of capture (loc). An invasive procedure was performed. The lead was surgically abandoned and replaced. The crt-p remains implanted and in service. No additional adverse patient effects were reported.
 
Event Description
Additional information was received that the patient was pacemaker dependent and experienced dizziness and weakness with the loc. The root cause is unknown.
 
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Brand NameINGENIO
Type of DeviceIMPLANTABLE PULSE 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
sonali vasekar
4100 hamline ave. n
st. paul, MN 
6515824786
MDR Report Key6193223
MDR Text Key62956530
Report Number2124215-2016-17179
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
P030005/S092
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 10/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/12/2017
Device Model NumberV273
Other Device ID NumberINTUA
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 Received10/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2015
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: 12/21/2016 Patient Sequence Number: 1
Treatment
1290; 4046; 4086; 4087; 4554; 7741; V273
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