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

Model Number F110

Device Problems Pocket Stimulation (1463); Low impedance (2285); Ambient Noise Problem (2877); Device Sensing Problem (2917)

Patient Problems Muscle Stimulation (1412); Ventricular Fibrillation (2130)

Event Date 03/19/2016

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.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.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) recorded noise on the competitor right atrial (ra) lead which appeared non physiologic in nature as well as noise on the competitor right ventricular (rv) lead resulting in oversensing.The patient was not dependent on ra or rv lead therapy.In addition low amplitudes were noted on the rv channel.A review of the cause by boston scientific technical services (ts) also noted a decrease in ra lead impedance measurements but not out of range.Subsequently the device was explanted an returned.No additional adverse patient effects were reported.

• 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: 7354421
• MDR Text Key: 102946681
• Report Number: 2124215-2018-03917
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/03/2010
• Device Model Number: F110
• Other Device ID Number: TELIGEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2009
• 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
• Treatment: 1580; F110; MISMATCH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR