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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 K083
Device Problems Over-Sensing (1438); Pacing Problem (1439); Use of Device Problem (1670)
Patient Problem Palpitations (2467)
Event Date 10/05/2017
Event Type  Injury  
Manufacturer Narrative
The device remains in service with no further complications reported. 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 about this case. The patient has not presented for a new follow up. The hospital planned to contact the boston scientific representative when the patient was available for a device check. No adverse patient effects were reported.
 
Manufacturer Narrative
The device remains in service. Additional investigation is being performed to determine whether the device was being reused, and why it was implanted after the ubd. The patient's next follow-up was scheduled for the next month, where the boston scientific field representative will request to save a copy of the device memory for engineering evaluation. This report will be updated when additional information is received.
 
Event Description
Boston scientific received information that the patient implanted with this pacemaker had presented to the hospital due to palpitations. A holter monitor study found a one second pause in pacing. The patient was hospitalized and the field representative interrogated the device. Lead measurements were all normal, but one episode was stored showing two beats of inhibited pacing due to farfield sensing. Sensitivity was adjusted to resolve the oversensing. The field representative observed a mismatch of patient data and implant date in the device. The patient told the representative what date the device was implanted and it was then considered that this device had likely been implanted in another patient previously. A review of the device tracking system showed this device had a use before date (ubd) of (b)(6) 2017 and the patient reported the device was implanted on (b)(6) 2017. No additional adverse patient effects were reported.
 
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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
tim degroot
4100 hamline ave. n
st. paul, MN 
6515826168
MDR Report Key7190520
MDR Text Key106894823
Report Number2124215-2017-19396
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/02/2017
Device Model NumberK083
Other Device ID NumberADVANTIO
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 Received02/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/15/2018 Patient Sequence Number: 1
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