MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3262

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

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2017

Event Type  malfunction  

Event Description

It was reported that the device was found in backup operation.Multiple attempts at performing a firmware upgrade on the pacemaker failed as the device was still in the box.After several failed attempts, the device went into backup operation.The device was returned for further analysis.

Manufacturer Narrative

The reported field event of backup vvi (bvvi) was confirmed in the laboratory consistent with effects of telemetry interruption.The device was tested on the bench and analysis performed after reloading product code indicated normal device characteristics.The cause of the bvvi was due to hardware, and this is consistent with effects of telemetry interruption, which was caused by the user during the firmware upgrade.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6925827
• MDR Text Key: 89505865
• Report Number: 2017865-2017-31821
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: PM3262
• Device Lot Number: A000028215
• Other Device ID Number: 05414734509091
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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