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

Model Number G148

Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problems Ventricular Fibrillation (2130); Patient Problem/Medical Problem (2688)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.This report will be updated should further information be received.

Event Description

Boston scientific received information that this device recorded a ventricular fibrillation (vf) episode at the time the patient received a computed tomography (ct) scan.The patient received a ct scan due to experiencing tremors.The vf resolved after the patient "thumped" their chest.Additionally it was noted that the device provided biventricular pacing during the vf episode.The field representative contacted boston scientific technical services (ts) for assistance.Ts reviewed the episode and discussed that the signals could indicate true vf or could indicate oversensing of the patient's tremors.The field representative indicated that the device interrogation results were normal following the ct scan.Ts recommended further testing to assess the impact of the tremor on device sensing.This device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

The physician believes the sensed signals were oversensing of the patient's tremors, not a true ventricular fibrillation (vf) episode.The clinic plans to continue monitoring this patient.This 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5603015
• MDR Text Key: 43478399
• Report Number: 2124215-2016-05533
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)20170618
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/05/2016

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: 06/18/2017
• Device Model Number: G148
• Other Device ID Number: INOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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
• Treatment: MISMATCH
• Patient Age: 61 YR