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

Model Number 5596

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

Patient Problem Heart Failure (2206)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented during a follow up in clinic.Upon investigation, it was noted that the pacemaker was found to be in backup vvi mode.The patient did not have any surgical or mri related procedure.The patient had symptoms of heart failure while lying down.Multiple attempts to restore the device failed and the device had not reached elective replacement indicator (eri).Device replacement was suggested.Additional information was not reported.

Event Description

New information received on (b)(6) 2018 notes that the device was still in bvvi and no device replacement was performed.

Event Description

New information received on 6/15/2018 notes that the device was explanted on (b)(6) 2018.Patient was stable and had recovered.

Event Description

New information received on 5/18/2018 notes that the device was explanted.Additional information was not reported.

Manufacturer Narrative

The field complaint of backup was confirmed.Device was received in backup mode with battery voltage at end of life (eol) level.Backup mode was triggered due to normal battery depletion.Testing performed after installing new battery and reloading product indicated normal device functionality.Battery longevity was estimated to be 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7431889
• MDR Text Key: 105531272
• Report Number: 2017865-2018-05784
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 5596
• Device Lot Number: 4875244
• Other Device ID Number: 05414734006941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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: 72 YR
• Patient Weight: 59