MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND COGNIS; IMPLANTABLE CHF PULSE GENERATOR

Model Number N107

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

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 following an unrelated procedure, it was observed the device had exhibited safety mode.Boston scientific technical services (ts) recommended device replacement.As a result, the device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.The device was confirmed to be in safety mode.Review of stored memory verified that the device experienced three system resets during the time of electrocautery use, which caused the device to go into safety mode.Of note, this family of devices has been specifically designed such that if three system resets occur within approximately 48 hours, a device will enter safety mode.The behavior of this device is consistent with devices that have reverted to safety mode due to electrocautery.Design changes have now been implemented to enhance the robustness of electric circuits, such that a device would be able to withstand the rare occurrences of conducted energy that previously would have disrupted circuit performance.

• Brand Name: COGNIS
• Type of Device: IMPLANTABLE CHF 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: 7195822
• MDR Text Key: 97397700
• Report Number: 2124215-2017-22679
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2010
• Device Model Number: N107
• Other Device ID Number: COGNIS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0185; 4555; MISMATCH; N107
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR