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 06/19/2017

Event Type  malfunction  

Event Description

It was reported that pulse generator exhibited backup vvi operation in the box.No patient involved in this event.

Manufacturer Narrative

The reported field event of backup vvi was confirmed in the laboratory and was due to power on reset with device id corrupted.The id bit corruption affected the devices ability to be recognized when interrogated with merlin programmer.Further analysis could not reproduce the anomalies and the cause of por could not be determined.All other test results were normal.

• 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: 6677735
• MDR Text Key: 78716448
• Report Number: 2017865-2017-05755
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/07/2017

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: 10/31/2018
• Device Model Number: PM3262
• Device Lot Number: A000039135
• Other Device ID Number: 05414734509091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• 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