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

Model Number P107

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Appropriate Term/Code Not Available (3191)

Patient Problems Atrial Tachycardia (1731); Unspecified Infection (1930)

Event Date 08/09/2014

Event Type  Injury  

Event Description

Boston scientific received information that this product was part of a system revision due to possible infection.Additional information received that the device caused pocket infection in the left infraclavicular region.It was noted that the device delivered inappropriate shock therapy for atrial arrhythmia.There were no additional adverse effects reported.The system was explanted.A new system was implanted on the right side of the patient.

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: 4149661
• MDR Text Key: 4770044
• Report Number: 2124215-2014-17348
• 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: Physician
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/09/2011
• 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
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2010
• 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: 0184; P107; MISMATCH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 50 YR