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

Model Number G140

Device Problems Low impedance (2285); Ambient Noise Problem (2877)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

Boston scientific received information that during a check of this implantable cardioverter defibrillator (icd) and right ventricular (rv) defibrillation lead while the patient was in the intensive care unit for unrelated reasons, upon holding the test button down, shock impedance measurements were noted to be 37, 38 and then 0, 0, 0, 37, 38 and 40 ohms.It was noted that the patient was connected to several external monitors.Additionally, noise was noted upon review of measurements.Technical services discussed the potential of emi from the external monitors and recommended checking again, once the monitors were no longer on the patient.Available information indicates that no further testing has been performed to determine the cause.No adverse patient effects were reported.This product remains implanted and in service.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A microscopic visual inspection of the device header and case noted body fluid contamination in the lead barrels and the device casing showed scratches and a dent.No issues were noted with the set screws.A hole was identified in the rv seal plug.Body fluid contamination was observed around the rv set screw connector block.Analysis of the device memory confirmed no battery faults or error codes occurred prior to explant.The battery status was at beginning of life (bol) when the device was returned.The device was then exposed to simulated heart load conditions, and the [defibrillation,] pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.It was concluded that since the device passed all testing, the issues observed in the field with noise and fluctuating impedances may have been a result of a lead-related issue.

Event Description

Additional information was received that the patient passed away two days later.Since it was already confirmed that the patient was in the icu for reasons unrelated to the device, the subsequent death was also likely not related.Since the call regarding the abnormal low shock lead impedance measurements, there have been no further issues reported.The device and lead were returned and are currently in analysis.Additional information was provided that the cause of death was due to cardiac arrest, cardiopulmonary arrest, and hypertension.

• 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: 6193740
• MDR Text Key: 62959532
• Report Number: 2124215-2016-19555
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: (01)00802526534539(17)20170203
• 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: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/03/2017
• Device Model Number: G140
• Other Device ID Number: INOGEN CRT-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2015
• 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: 0295; 4470; 4554; 4591; G140
• Patient Age: 78 YR