MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND RESONATE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number G447

Device Problems Device Alarm System (1012); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

No further investigation required.Information from field sufficient to make accurate reporting decisions.Should new information become available, this event will be further reviewed.

Event Description

Boston scientific received information that the patient with this device sought medical assistance due to beep tones.A latitude data request was filed to investigate for any system performance issues.The review illustrated high out of range left ventricular (lv) and right atrial (ra), lead pacing impedance measurements.The technical services consultant was able to confirm the tones were associated with an lv impedance greater than 2000 ohms.Patient data was suggestive of programming changes within the past few months due to the marked change in not only impedance but thresholds, at this timepoint.Ts recommended a programming change to set impedance alert notifications, at greater than 3000 ohms.The data review confirmed ra lead impedances measurement had been high since implant with the field representative confirming the system has no ra lead connected.No resulting adverse patient effects were reported and to date the device remains implanted and in service; no lv lead information was able to be obtained.

• Brand Name: RESONATE
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 7375523
• MDR Text Key: 103676059
• Report Number: 2124215-2018-05511
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2019
• Device Model Number: G447
• Other Device ID Number: RESONATE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2017
• 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