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

Model Number G146

Device Problems Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 10/16/2016

Event Type  Injury  

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 the patient was hospitalized for cardiopulmonary arrest.Upon interrogation it was noted that the left ventricular (lv) pacing was being inhibited.Boston scientific technical services (ts) was consulted and discussed, however ultimately what was being sensed in the lv and causing the pacing inhibition was unable to be determined.Several different programming considerations were attempted, eventually the device and lv lead were programmed back to the original setting and the issue did not reoccur.At this time they have opted to continue to monitor the patient and no additional adverse patient effects were reported.The cardiac resynchronization therapy defibrillator (crt-d) and lv lead remain 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6237876
• MDR Text Key: 64374909
• Report Number: 2124215-2016-18243
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: (01)00802526534577(17)20160527
• 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
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/27/2016
• Device Model Number: G146
• 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
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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
• Treatment: 0184; 4136; 4677; E102; G146; T135
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR