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

Model Number 5596

Device Problem Pacemaker Found in Back-Up Mode (1440)

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

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The cause of the reported incident could not be conclusively determined, but based on the information received, it was likely due to the use of electrocautery.

Event Description

During device replacement for normal eri, the device went into back-up mode due to the use of electrocautery.An external pacing system analyzer (psa) was used during the substitution and the patient experienced symptoms of dizziness at this time.The device was explanted and replaced and the patient was stable following the procedure.

• Brand Name: FRONTIER II
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7052965
• MDR Text Key: 92765032
• Report Number: 2017865-2017-34921
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: 5596
• Device Lot Number: 3102033
• Other Device ID Number: 05414734006941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2010
• 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