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

Model Number G148

Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)

Patient Problems Palpitations (2467); No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2016

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) and another manufacturer's right atrial (ra) lead were exhibiting noise and oversensing.There was also an increase in pacing impedance values from 500 to 1,200 ohms.The respiratory rate trend was turned off.The right ventricular rate/sense and shock channels indicated appropriate ventricular activity.It was recommended by a boston scientific technical services (ts) consultant to change the sensitivity and turn on additional alerts to be notified if the signals are sensed again.No adverse patient effects were reported.

Manufacturer Narrative

Additional information received indicated that the patient experienced palpitations when the 112 lead ekg was taken.The local field representative performed isometrics and pocket manipulations.There was no noise or change in impedance noted.There also had been no new stored events.The physician elected to increase the ra output from 2 volts to 5 volts at 0.4 milliseconds.

Event Description

Additional information received indicated that loss of capture (loc) was identified when this patient was having a 12- lead electrocardiogram.Upon further review, it was identified that there was non-capture when the pacing impedance measurements were greater than 1,000 ohms, but capture returned when the pacing impedances decreased to 500 ohms.

• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6246202
• MDR Text Key: 64721728
• Report Number: 2124215-2016-21369
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)20170529
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

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: 05/29/2017
• Device Model Number: G148
• Other Device ID Number: INOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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: 0292; 5076; G148; MISMATCH
• Patient Age: 81 YR