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

Model Number F110

Device Problems Device Alarm System (1012); Premature Discharge of Battery (1057)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2015

Event Type  Injury  

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

Boston scientific received information that this device was emitting tones.Upon interrogation it was noted that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.No adverse patient effects were reported.The device was explanted and is not expected to be returned for analysis.Boston scientific has issued an advisory communication regarding an older subset of cognis/teligen devices that is more susceptible to a product performance anomaly.Specifically, the performance of a low voltage capacitor may be compromised over time, causing an increased current drain that can lead to premature battery depletion.This particular device was included in the advisory population.

• Brand Name: TELIGEN
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5371218
• MDR Text Key: 36207369
• Report Number: 2124215-2015-14836
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• 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: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/21/2010
• Device Model Number: F110
• Other Device ID Number: TELIGEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0088-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR