MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD FRONTIER II; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5596

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2011

Event Type  Injury  

Event Description

It was reported that the pulse generator exhibited inappropriate measured data.The device was explanted and replaced.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.Analysis was normal.No anomaly was found.

• Brand Name: FRONTIER II
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3661871
• MDR Text Key: 21805424
• Report Number: 2017865-2014-10213
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2007
• Device Model Number: 5596
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2011
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/27/2011
• Device Age: 70 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/11/2011
• Date Device Manufactured: 01/24/2006
• 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 Outcome(s): Required Intervention