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

Model Number	5586
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8157875
• Report Number: 2017865-2018-18790
• Device Sequence Number: 1625441
• Product Code: NKE
• UDI-Device Identifier: 05414734502948
• UDI-Public: 05414734502948
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 01/16/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 12/14/2018; 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR