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

Model Number G177

Device Problems Device Alarm System (1012); Low impedance (2285)

Patient Problem Fall (1848)

Event Date 01/01/2015

Event Type  malfunction  

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.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was emitting tones.Interrogation identified intermittent low out-of-range right atrial (ra) lead pacing impedances dating back to (b)(6) 2015.The change in impedances correlates to the same time the patient experienced a serious fall.The patient is not pacemaker dependent for ra therapy.The device was reprogrammed to prevent any inappropriate therapy.There were no adverse patient effects.

• 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 ; 6515824786
• MDR Report Key: 5174395
• MDR Text Key: 29823277
• Report Number: 2124215-2015-12025
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2015
• Device Model Number: G177
• 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: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2014
• 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