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

Model Number G141

Device Problems Device Alarm System (1012); High impedance (1291); Ambient Noise Problem (2877)

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

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

At this time, the device remains in service.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was emitting tones.The device and a non-boston scientific right ventricular (rv) lead exhibited impedance measurements of greater than 2000 ohms in the recent past.It was noted that impedance measurements had otherwise been stable and within normal limits.There was also noise noted in the non-boston scientific right atrial (ra) lead.Patient isometrics and pocket manipulation were performed which did not elicit any noise or changes to the impedance measurements.The device was reprogrammed and the patient would continue to be monitored.No adverse patient effects were reported.The device remains in service.

• 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: 7196144
• MDR Text Key: 97790234
• Report Number: 2124215-2017-23089
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: 00802526534553
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/28/2017

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: 09/29/2017
• Device Model Number: G141
• Other Device ID Number: INOGEN 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: 11/28/2017
• Initial Date FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2015
• 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
• Patient Age: 79 YR