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

Model Number G179

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

Boston scientific received information that during implant, the physician reported right ventricular lead insertion difficulty into this device's header.The device was successfully implanted and to date, remains in service with no further reported complications.

Manufacturer Narrative

(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: AUTOGEN
• 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 55112 ; 6515824786
• MDR Report Key: 3904549
• MDR Text Key: 18366844
• Report Number: 2124215-2014-11789
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• 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: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2015
• Device Model Number: G179
• Other Device ID Number: AUTOGEN 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: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2013
• 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: G179; 4671; 0295