MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ALLURE MP CRT-P

Model Number PM3562

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

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2017

Event Type  malfunction  

Event Description

Prior to procedure, interrogation of the device showed it was in backup vvi mode.There were no patient consequences.

Manufacturer Narrative

The device was in backup mode when received, with battery voltage at beginning of life (bol) level.Device image indicated bvvi occurred on (b)(6) 2017.The unit was returned from taunton, uk which had temperature down to 2°c or lower around the time bvvi occurred.The failure mode was reproduced in lab when the device was exposed to 0°c.Backup operation was likely caused by cold temperature sensitivity from the xena ic.The reported complaint of backup mode prior to implant was confirmed.

• Brand Name: QUADRA ALLURE MP CRT-P
• Type of Device: QUADRA ALLURE MP CRT-P
• 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: 6463517
• MDR Text Key: 72194587
• Report Number: 2017865-2017-02073
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030035
• 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: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: PM3562
• Device Lot Number: P000038813
• Other Device ID Number: 05414734510097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2016
• 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