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

Model Number G148

Device Problems High impedance (1291); Fitting Problem (2183); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2014

Event Type  malfunction  

Event Description

Boston scientific received information that during the implant procedure, difficulty was experienced inserting the right ventricular (rv) and left ventricular (lv) lead terminal pins into the header of this cardiac resynchronization therapy defibrillator (crt-d).Noise and high pacing impedance measurements were observed.The connections were tried multiple times; the rv lead was reconnected three times and the lv lead was reconnected four times.The physician did not use saline water or mineral oil to aid in the lead insertion process.However, the physician did ensure the terminal pins were wiped clean prior to insertion.It was noted one lv pacing configuration exhibited out-of-range impedance and no measurable pacing threshold, but this resolved itself during the procedure.All impedance measurements were then within normal range.The system was successfully implanted.No adverse patient effects were reported.

Manufacturer Narrative

(b)(4).The device and leads remain in service without further complication.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: 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 55112 ; 6515824786
• MDR Report Key: 3904542
• MDR Text Key: 17263417
• Report Number: 2124215-2014-11755
• 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: 12/10/2015
• Device Model Number: G148
• 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: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2014
• 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: G148; 0293; 4096; 4671
• Patient Age: 64 YR