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

Model Number E110

Device Problems Device Alarm System (1012); High impedance (1291); Device Displays Incorrect Message (2591); Ambient Noise Problem (2877)

Patient Problems Syncope (1610); Fall (1848); Bone Fracture(s) (1870); Ventricular Tachycardia (2132)

Event Date 10/01/2017

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 the patient implanted with this implantable cardioverter defibrillator (icd) and right ventricular (rv) defibrillation lead experienced a syncopal episode, fell and broke an ankle approximately 4 months ago.The patient reported that the device had been emitting beeping tones ever since.Review of stored device memory during a routine in clinic device follow up noted the device recorded a shock lead open message that correlated with a stored ventricular tachycardia (vt) episode and syncope.The device appropriate detected and delivered anti-tachycardia pacing (atp) and shock therapy, which, slowed the rhythm.High out of range shock impedance measurements greater than 125 ohms were recorded with shock delivery and resulted in the beeping tones.Review of daily measurements noted a gradual increase in shock impedance measurements with intermittent out of range measurements approximately beginning 6 months ago.Farfield signals from the rv were observed on the right atrial (ra) channel, however, were appropriately blanked.Boston scientific technical services (ts) discussed that shock therapy may not be effective with the high shock impedance measurements and discussed the option of replacing the lead.No additional adverse patient effects were reported.This product remains implanted and in service.

• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7615311
• MDR Text Key: 111645285
• Report Number: 2124215-2018-07885
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/11/2018

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: 05/28/2010
• Device Model Number: E110
• 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
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2009
• 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: 65 YR