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

Model Number G148

Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2018

Event Type  malfunction  

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 with cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead had high out of range pacing impedance greater that 2000 ohms, where the minute ventilation (mv) signal was being oversensed.The mv feature was turned off in response, and the plan was to continue to monitor.The device remains in-service.No adverse patient effects were reported.

• 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: 7727504
• MDR Text Key: 115361036
• Report Number: 2124215-2018-13694
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2017
• Device Model Number: G148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2015
• 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
• Patient Age: 68 YR