MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VICTORY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5816

Device Problems False Alarm (1013); Electromagnetic Interference (1194)

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

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

During a follow-up, the pacemaker displayed a false elective replacement indicator (eri) potentially due to a period of intensive pacing or electromagnetic interference.The eri was cleared and the pacemaker displayed the correct longevity.The patient was stable.

Manufacturer Narrative

The device image showed that the elective replacement indicator (eri) flag was triggered while battery voltage was still above eri.Field data indicated that device was also programmed to rate responsive mode with elevated pacing output.When an automatic setting is programmed, such as rate responsive mode, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of the device and cause the eri flag to be falsely triggered.Analysis performed did not find any anomaly and the battery voltage was still within normal range.

Event Description

The device was electively explanted and returned for investigation.

• Brand Name: VICTORY XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6216897
• MDR Text Key: 63695572
• Report Number: 2017865-2016-08098
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2008
• Device Model Number: 5816
• Device Lot Number: 2955446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2006
• 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): Hospitalization; Other
• Patient Age: 68 YR