MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FRONTIER II; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5586

Device Problem No Device Output (1435)

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

Event Date 02/09/2017

Event Type  malfunction  

Event Description

It was reported that during a scheduled pulse generator change out procedure, the device exhibited a loss of output and asystole was noted for several seconds.The patient was externally paced.The device was successfully explanted and replaced.No additional information was reported.

Manufacturer Narrative

Final analysis found burn marks on the device can as a result of exposure to electrocautery.The device manual notes that exposure to electrocautery may cause asynchronous or inhibited device operation.All other testing determined normal device characteristics.

Event Description

New information reported on (b)(6) 2017 stated that during the previously reported procedure exposure to electrocautery was used; after the exposure is when the device lost all function.The patient was in stable condition during and after procedure.

• Brand Name: FRONTIER II
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6519654
• MDR Text Key: 73621708
• Report Number: 2017865-2017-02558
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2008
• Device Model Number: 5586
• Device Lot Number: 0002134411
• Other Device ID Number: 05414734502948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2007
• 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: 66 YR