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

Model Number G179

Device Problems High impedance (1291); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2013

Event Type  malfunction  

Event Description

Boston scientific received information that during the implant of this cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead, difficulties were encountered connecting the lead to the device.The physician first put the torque wrench into the setscrew before pushing the lead's terminal pin into the port.After the setscrew was engaged and measurements were obtained, all values were in normal range with the exception of the shock impedance measurement which was above 200 ohms.Several attempts were made to disconnect the lead and reconnect it in the device port but the above 200 ohms shock impedance measurement was still obtained.The physician then delivered a low energy shock to test the connection and the above 200 ohms measurement was again observed.The rv lead was disconnected again and mineral oil was then applied to the lead's terminal pin and then it was inserted into the device port.After this was performed, the shock impedance measurement was 80 ohms.No adverse patient effects were reported.The crt-d and rv lead were successfully implanted and remain in service.

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: 3904563
• MDR Text Key: 21721843
• Report Number: 2124215-2014-11765
• 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: Health Professional
• Device Expiration Date: 10/29/2015
• 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: 11/28/2013
• 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; 4677; 0692; 4480