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

Model Number P107

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Atrial Tachycardia (1731)

Event Date 02/16/2015

Event Type  malfunction  

Event Description

Boston scientific received information that the implantable cardioverter defibrillator (icd) delivered several inappropriate shocks due to oversensing the patients atrial arrhythmia.Consequentially, this resulted in device therapy exhaustion for this patient.No known intervention was taken and the system remains implanted.It was reported that this patient is do not resuscitate (dnr).No further adverse patient effects were reported.

Manufacturer Narrative

(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: COGNIS
• Type of Device: IMPLANTABLE CHF PULSE 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 55112 ; 6515824786
• MDR Report Key: 4657273
• MDR Text Key: 5609148
• Report Number: 2124215-2015-03762
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/25/2015

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: 10/20/2011
• Device Model Number: P107
• Other Device ID Number: COGNIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2010
• 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: P107
• Patient Age: 87 YR