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

Model Number G146

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

Boston scientific received information that during a follow-up appointment, there was a stored episode with this cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead which indicated noise and oversensing.The noise was able to be reproduced with isometrics/pocket maneuvers.Subsequently, the patient had surgery and received a new tricuspid valve and a new mitral valve.During surgery, the rv, the left ventricular (lv) lead and the device were removed.A new rv and lv epicardial leads were implanted.A new pacemaker was also implanted.The patient planned to receive a subcutaneous implantable cardioverter defibrillator (s-icd) at a later date.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.A visual inspection of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: INOGEN
• Type of Device: IMPLANTABLE CHF 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: 7983880
• MDR Text Key: 124303592
• Report Number: 2124215-2018-18129
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2015
• Device Model Number: G146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• 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; 4671; 5568; G146
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention