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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 J176
Device Problems Electrical /Electronic Property Problem (1198); Reset Problem (3019)
Patient Problem Atrial Flutter (1730)
Event Date 01/27/2016
Event Type  Injury  
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 the patient implanted with this pacemaker was found to be in atrial flutter during a normal follow up clinic visit. The physician attempted to cardiovert the patient by using atrial burst pacing however a warning screen displayed on the programmer informing the physician that the device was now operating in safety mode. Boston scientific technical services (ts) recommended device replacement. No adverse patient effects were reported. The device was explanted and is expected to be returned for analysis.
 
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 no anomalies. The device was confirmed to be in safety mode. The device was programmed out of safety mode and back into operation mode. The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested. Impedance testing was completed and all measurements were within normal limits. Examination of the device memory confirmed that the device went into safety mode as a result of experiencing firmware resets. This family of devices has been specifically designed such that if three system resets occur within a 48-hour period, a device will enter safety mode.
 
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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 Key5599565
MDR Text Key43439296
Report Number2124215-2016-02756
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
N/A
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 03/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/09/2015
Device Model NumberJ176
Other Device ID NumberINGENIO MRI
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2013
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: 04/22/2016 Patient Sequence Number: 1
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