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

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.

• Brand Name: ACCOLADE
• Type of Device: IMPLANTABLE 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 Key: 7615438
• MDR Text Key: 111673857
• Report Number: 2124215-2018-08363
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• 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 Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/28/2019
• Device Model Number: U228
• Other Device ID Number: VISIONIST X4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• 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