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U.S. Department of Health and Human Services

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

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GUIDANT CRM CLONMEL IRELAND ACCOLADE IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number U228
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2018
Event Type  Injury  
Manufacturer Narrative
No further information has been provided to date. This report will be updated should additional information become available.
 
Event Description
Boston scientific received information that this device was found in safety mode. Boston device data analysis was performed and it was noted that safety mode may have occurred as the result of left ventricular (lv) offset programmed to a positive value in conjunction with other device settings. Boston scientific technical services (ts) recommended device replacement. No adverse patient effects were reported. This system remains in service at this time.
 
Manufacturer Narrative
The product is expected to be returned for analysis. This report will be updated upon return and completion of analysis.
 
Event Description
Additional information was received indicating this device was explanted and replaced. No adverse patient effects were reported.
 
Manufacturer Narrative
This crt-p was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory. External visual inspection of the device noted tool marks on the header; no other anomalies were found. The battery status was at beginning of life (bol) with a voltage of 2. 994 volts and the device¿s operating power levels were within normal parameters. A review of the device memory confirmed that the device was in safety mode status and that several lv low rate pacing monitor alerts were recorded. A telemetry reset command was then issued with an engineering-level programmer to remove the device from safety mode status and program the device back into primary operation. A series of automated electrical and functional tests were performed; the device passed all testing requirements, sensing and pacing functions were verified. Deeper engineering analysis of the device memory confirmed that this device experienced a lv low rate pacing monitor reset due to a programming interaction involving a large positive lv offset when the rvat test and atr mode switch occurred on the same cardiac cycle. The large positive lv offset allowed enough time after the rv pace for the rvat test to be started and then aborted due to an atr. This, in turn, caused the scheduled lv pace to be canceled when the device was starting to change bradycardia parameters while the temporary rvat test parameters were still enabled. This situation occurred two more times, each within 48 hours of the previous reset, thus triggering the device to enter into safety mode.
 
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Brand NameACCOLADE
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 Key7615438
MDR Text Key111673857
Report Number2124215-2018-08363
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2019
Device Model NumberU228
Other Device ID NumberVISIONIST X4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2017
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: 06/19/2018 Patient Sequence Number: 1
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