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

Model Number 5586

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Data Problem (3196)

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

Event Date 07/22/2018

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 for routine pulse generator replacement.Upon device interrogation prior to the procedure, it was discovered that only basic parameters were available.No battery information could be obtained.The physician had noted that on (b)(6) 2018 the remaining longevity was a year but the device prematurely reached elective replacement indicator on (b)(6) 2018.The device was explanted and replaced.The patient was stable.

Event Description

New information receives stated that per physician the battery estimated one year remaining; however, a month later device reached elective replacement indicator.It was also noted that there was no communication with the device.It was mentioned that the battery had one year remaining in (b)(6) 2018 and patient presented in office in eri six months later.

Manufacturer Narrative

The reported event of premature battery depletion was not confirmed.Device was received in backup vvi mode, and at eri voltage level.Analysis of device image indicated that the backup operation has occurred post explant due to exposure to cold temperature.The false eri triggered about three months before the explant date which resulted from transient low battery voltage, consistent with high pacing output usage.Longevity assessment was performed based on field settings and it has met the projected longevity.

• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8157875
• MDR Text Key: 130164998
• Report Number: 2017865-2018-18790
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734502948
• UDI-Public: 05414734502948
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2009
• Device Model Number: 5586
• Device Lot Number: 0002134101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 12/10/2018; 01/16/2019
• Supplement Dates FDA Received: 12/14/2018; 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2008
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR