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

Model Number 5596

Device Problem Failure to Disconnect (2541)

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

Event Date 06/06/2017

Event Type  malfunction  

Event Description

During device replacement, there were difficulties loosening the screw holding the right ventricular lead due to dried blood in the screw head slot.The blood was rinsed out and the lead was removed.The patient was reported to be stable.

Manufacturer Narrative

Visual inspection of the header revealed that rv set screw was damaged and stripped.It was also noted that top of the rv set screw had some blood and small pieces of septum in it.The cause for the reported issue was related to stripping of the set screw during explant.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6723917
• MDR Text Key: 80384505
• Report Number: 2017865-2017-06735
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2010
• Device Model Number: 5596
• Device Lot Number: 2913168
• Other Device ID Number: 05414734006941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2008
• 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 Age: 87 YR