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

Model Number G140

Device Problems Device Alarm System (1012); High impedance (1291); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2017

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 due to a shock impedance measurement of 140 ohms.The shock impedance alert was increased to 175 ohms.Additionally, there was a right ventricular (rv) lead in the right atrial (ra) port of the device.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: 7407037
• MDR Text Key: 104776118
• Report Number: 2124215-2018-01375
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: 00802526534539
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/03/2018

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: 06/20/2017
• Device Model Number: G140
• Other Device ID Number: INOGEN CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2015
• 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; 1291; 1298; 4136; 4537; G140; K063; MISMATCH
• Patient Age: 77 YR