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 Loss Of Pulse (2562)

Event Date 04/03/2017

Event Type  Injury  

Event Description

It was reported that patient presented to the hospital for a generator change due to normal eri.During the procedure, the device exhibited temporarily loss of output, as a result of the cautery exposure.The patient experienced asystole, and the patient was connected to a temporary pacing system.The procedure continued without complication.The patient was stable and in good condition prior to and post procedure.

Manufacturer Narrative

The damage found was sustained during the surgical procedure.The device was otherwise normal.

• 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: 6574329
• MDR Text Key: 75399685
• Report Number: 2017865-2017-02695
• 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
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2008
• Device Model Number: 5586
• Device Lot Number: 0002134181
• Other Device ID Number: 05414734502948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2007
• 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 Outcome(s): Required Intervention
• Patient Age: 82 YR