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

Model Number G141

Device Problems High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Displays Incorrect Message (2591); Ambient Noise Problem (2877)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) oversensed noise on the right ventricular (rv) channel that led to the delivery of an inappropriate shock.The shock impedance was high and out of range and the device recorded a code to alert that the shock impedance was measured at greater than 145 ohms.The physician suspects that the rv lead is fractured and has turned tachy therapy off.A request was made of boston scientific technical services (ts) to review the system.Ts confirmed that a code for high shock impedances was recorded and recommended replacing the rv lead and performing testing.This crt-d and the rv lead remain in service.No adverse patient effects were reported.

Event Description

Additional information was received that indicated that a revision procedure was performed.Both the rv lead and this crt-d were replaced.This crt-d was explanted.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.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.It is concluded that the device meets specifications.The allegation from the field may have been a result of a lead issue.

• 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: 7631289
• MDR Text Key: 112183461
• Report Number: 2124215-2018-11243
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2018
• Device Model Number: G141
• Other Device ID Number: INOGEN CRT-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 06/22/2018; 08/13/2018
• Supplement Dates FDA Received: 07/16/2018; 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• 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
• Patient Age: 61 YR