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

Model Number G146

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Syncope (1610)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Boston scientific received information that this patient blacked out and has had other episodes similar to that.The patient has previously followed-up with their cardiologist.The patient reportedly has lots of scar tissue in his heart and was to follow-up again with their cardiologist.No additional adverse patient effects were reported.The field representative has reached out to the clinic for further information and does not have further information to report at this time.

• 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: 7654451
• MDR Text Key: 112858370
• Report Number: 2124215-2018-11784
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: (01)00802526534577(17)20170330
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2017
• Device Model Number: G146
• Other Device ID Number: INOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• 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: 0144; 0926; 1831; 4244; 4260; 4270; 4470; A135; E030; G146; MISMATCH; T167
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR