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

Model Number G172

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877); Device Sensing Problem (2917)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/19/2015

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) displayed noise on the right atrial channel as well as the shock electrocardiogram prior to the noise noted on the right atrial channel.An inquiry was made for technical review of this case.Boston scientific technical services (ts) noted oversensing of the minute ventilation signal which was generated by the device on the atrial lead.Ts also noted and discussed the noise seen the shock channel is likely muscle noise that is picked up because the shock egm is unipolar sensing from the distal coil to the can.Ts further discussed the mv signal usage and noted that the device would not oversense this signal but there have been cases where this can happen if the impedance between the ra ring and can is large.Ts further discussed that the atrial sensing is on the lower side thus the 'check atrial lead' message showing up, all other lead diagnostics were good and stable.Ts discussed that anti tachy cardia episode appeared to be oversensing on the atrial channel.Noted that since patient was at home electromagnetic interference was not likely.Ts noted that the device does have the minute ventilation (mv) sensor on at passive and the signal is 50ms thus there is something intermittent that is allowing the device to oversense the mv single on the atrial channel as the atrial lead is the default lead to use for the mv sensing.Ts noted that this particular case appeared to be intermittent and no out of range pacing impedances were seen.Programming options were also discussed for optimization.No further actions were taken and a normal patient follow up was scheduled.This device remains implanted.No adverse patient effects were reported.

• Brand Name: AUTOGEN
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5373420
• MDR Text Key: 36540490
• Report Number: 2124215-2016-00517
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/08/2016
• Device Model Number: G172
• Other Device ID Number: AUTOGEN CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• 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
• Patient Age: 79 YR